Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-01-06 @ 2:06 PM
Study NCT ID:
NCT03187834
Status:
COMPLETED
Last Update Posted:
2023-03-02
First Post:
2017-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014141', 'term': 'Trachoma'}], 'ancestors': [{'id': 'D003234', 'term': 'Conjunctivitis, Bacterial'}, {'id': 'D015818', 'term': 'Eye Infections, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D002690', 'term': 'Chlamydia Infections'}, {'id': 'D002694', 'term': 'Chlamydiaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003316', 'term': 'Corneal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D015662', 'term': 'Trimethoprim, Sulfamethoxazole Drug Combination'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013420', 'term': 'Sulfamethoxazole'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D014295', 'term': 'Trimethoprim'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tom.lietman@ucsf.edu', 'phone': '415-502-2662', 'title': 'Dr. Thomas Lietman', 'organization': 'F.I. Proctor Foundation, University of Califonia, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'days 1-5', 'description': 'On each day of treatment, caregivers were asked if the child had any symptoms since the previous day, including gastrointestinal symptoms, respiratory symptoms, a rash, or any other symptoms. Four days after the last treatment dose, caregivers were asked if their child had had three or more loose or watery stools over a 24-hour period, consistent with the WHO definition of diarrhea,21 and if the child currently had a cough or difficulty breathing.', 'eventGroups': [{'id': 'EG000', 'title': 'Amoxicillin Households - Antibiotic', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, twice a day as is:\n\nAmoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5\n\nAmoxicillin Households - Antibiotic: Children in this arm will receive Amoxicillin twice a day.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 5, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Amoxicillin Households - Placebo', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nAmoxicillin Households - Placebo: Children in this arm will receive Placebo.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Azithromycin Households - Antibiotic', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nAzithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5\n\nAzithromycin Households - Antibiotic: Children in this arm will receive Azithromycin once a day.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 3, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Azithromycin Households - Placebo', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nAzithromycin Households - Placebo: Children in this arm will receive Placebo.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 5, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cotrimoxazole Households - Antibiotic', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nCo-trimoxazole: 240 mg daily for Days 1-5\n\nCotrimoxazole: Children in this arm will receive co-trimoxazole once a day. Cotrimoxazole: Children in this arm will receive co-trimoxazole once a day.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 3, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cotrimoxazole Households - Placebo', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nCotrimoxazole Households - Placebo: Children in this arm will receive Placebo.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 3, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Placebo', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. In placebo households, both children received placebo.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 7, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting, days 1-5', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea, days 1-5', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever, days 1-5', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough, Days 1-5', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough, Day 9', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea, days 1-5', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea, day 9', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Simpson's Index of Diversity (Alpha Diversity) in Intestinal Microbiome", 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, twice a day as is:\n\nAmoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5 Amoxicillin Households - Antibiotic: Children in this arm will receive Amoxicillin twice a day.'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving Azithromycin versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm and treated for 5 days.\n\nChildren will receive treatment everyday, once a day as is:\n\nAzithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5\n\nAzithromycin: Children in this arm will receive Azithromycin once a day.'}, {'id': 'OG002', 'title': 'Cotrimoxazole', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving Cotri-moxazole versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.\n\nChildren will receive treatment everyday, once a day as is:\n\nCo-trimoxazole: 240 mg daily for Days 1-5\n\nCotrimoxazole: Children in this arm will receive co-trimoxazole once a day.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving placebo versus children receiving antibiotics Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.\n\nChildren will receive Placebo everyday, once a day.\n\nPlacebo: Children in this arm will receive Placebo once a day.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '11.5'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '10.1'}, {'value': '9.7', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '11.2'}, {'value': '9.6', 'groupId': 'OG003', 'lowerLimit': '8.6', 'upperLimit': '10.7'}]}]}, {'title': 'Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '9.6'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '7.8'}, {'value': '8.3', 'groupId': 'OG002', 'lowerLimit': '6.9', 'upperLimit': '9.7'}, {'value': '9.8', 'groupId': 'OG003', 'lowerLimit': '8.7', 'upperLimit': '10.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 9', 'description': "The primary outcome of the study was pre-specified as α-diversity (inverse Simpson's) at the genus level, expressed in effective number. Simpson's Alpha Diversity were obtained at Baseline and Post-treatment in this study. The minimum of Simpson's index of diversity is 0, there is no maximum. Higher Simpson's index of diversity means more diverse. There are no subscales.", 'unitOfMeasure': 'Index score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '248 children in 124 households were enrolled and randomized to 1 of the 3 antibiotic regimens or placebo. Of these, 124 children were randomized within their household to receive treatment and are included in this analysis. Of these children, 9 children were lost to follow-up.\n\nThe samples from Amoxicillin Households - Placebo, Azithromycin Households - Placebo, Cotrimoxazole Households - Placebo and half of placebo (31 participants) were not collected and analyzed, due to limited budget.'}, {'type': 'SECONDARY', 'title': "Simpson's Index of Diversity (Alpha Diversity) in Microbiome", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin Households', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, twice a day as is:\n\nAmoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5\n\nAmoxicillin Households - Antibiotic: Children in this arm will receive Amoxicillin twice a day.'}, {'id': 'OG001', 'title': 'Azithromycin Households', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nAzithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5\n\nAzithromycin Households - Antibiotic: Children in this arm will receive Azithromycin once a day.'}, {'id': 'OG002', 'title': 'Cotrimoxazole Households', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nCo-trimoxazole: 240 mg daily for Days 1-5\n\nCotrimoxazole: Children in this arm will receive co-trimoxazole once a day.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. In placebo households, both children received placebo.'}], 'timeFrame': 'Day 9', 'description': 'Direct and indirect effect of antibiotics on alpha diversity from rectal samples', 'reportingStatus': 'POSTED', 'populationDescription': 'rectal samples were not analyzed due to limited budget - samples were collected but not analyzed and never will be analyzed'}, {'type': 'SECONDARY', 'title': 'Weight-for-height Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, twice a day as is:\n\nAmoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5 Amoxicillin Households - Antibiotic: Children in this arm will receive Amoxicillin twice a day.'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nAzithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5 Azithromycin Households - Antibiotic: Children in this arm will receive Azithromycin once a day.'}, {'id': 'OG002', 'title': 'Cotrimoxazole', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nCo-trimoxazole: 240 mg daily for Days 1-5 Cotrimoxazole: Children in this arm will receive co-trimoxazole once a day.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. In placebo households, both children received placebo.'}], 'classes': [{'title': 'Children who received Antibiotic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '-0.27', 'spread': '0.91', 'groupId': 'OG002'}]}]}, {'title': 'Children who received Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.52', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '-0.49', 'spread': '1.11', 'groupId': 'OG002'}, {'value': '-0.28', 'spread': '1.00', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 35', 'description': 'Nutritional status as determined by weight-for-height Z-score vs. Placebo household Weight-for-height Z-score in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Weight-for-height Z (WHZ) scores were calculated based on the 2006 World Health Organization (WHO) standards. The mean of the 2006 population standards is 0. Lower standard deviations = worse outcomes. A cutoff of \\< -2 means moderately wasted (WHZ). A cutoff of \\< -3 means wasted (WHZ).', 'unitOfMeasure': 'z score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In Amoxicillin, Azithromycin, Cotrimoxazole households, children assigned to receive antibiotic and placebo were analyzed separately, showed in different row below.'}, {'type': 'SECONDARY', 'title': 'Height-for-age Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, twice a day as is:\n\nAmoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5 Amoxicillin Households - Antibiotic: Children in this arm will receive Amoxicillin twice a day.'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nAzithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5 Azithromycin Households - Antibiotic: Children in this arm will receive Azithromycin once a day.'}, {'id': 'OG002', 'title': 'Cotrimoxazole', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nCo-trimoxazole: 240 mg daily for Days 1-5 Cotrimoxazole: Children in this arm will receive co-trimoxazole once a day.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. In placebo households, both children received placebo.'}], 'classes': [{'title': 'Children who received Antibiotic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.80', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '-0.92', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '-0.69', 'spread': '1.00', 'groupId': 'OG002'}]}]}, {'title': 'Children who received Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.73', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '-1.16', 'spread': '1.34', 'groupId': 'OG001'}, {'value': '-1.38', 'spread': '0.94', 'groupId': 'OG002'}, {'value': '-0.59', 'spread': '1.08', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 35', 'description': 'Nutritional status as determined by height-for-age Z-score Height-for-age Z-score in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Height-for-age Z (HAZ) score were calculated based on the 2006 World Health Organization (WHO) standards. The mean of the 2006 population standards is 0. Lower standard deviations = worse outcomes. A cutoff of \\< -2 means moderately stunted (HAZ). A cutoff of \\< -3 means severely stunted (HAZ).', 'unitOfMeasure': 'z score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In Amoxicillin, Azithromycin, Cotrimoxazole households, children assigned to receive antibiotic and placebo were analyzed separately, showed in different row below.'}, {'type': 'SECONDARY', 'title': 'Weight-for-age Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, twice a day as is:\n\nAmoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5 Amoxicillin Households - Antibiotic: Children in this arm will receive Amoxicillin twice a day.'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nAzithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5 Azithromycin Households - Antibiotic: Children in this arm will receive Azithromycin once a day.'}, {'id': 'OG002', 'title': 'Cotrimoxazole', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nCo-trimoxazole: 240 mg daily for Days 1-5 Cotrimoxazole: Children in this arm will receive co-trimoxazole once a day.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. In placebo households, both children received placebo.'}], 'classes': [{'title': 'Children who received Antibiotic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.60', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '-0.58', 'spread': '0.94', 'groupId': 'OG002'}]}]}, {'title': 'Children who received Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '-0.78', 'spread': '1.02', 'groupId': 'OG001'}, {'value': '-1.12', 'spread': '1.04', 'groupId': 'OG002'}, {'value': '-0.53', 'spread': '0.97', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 35', 'description': 'Nutritional status as determined by weight-for-age Z-score vs. Placebo household Weight-for-age Z-score in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Weight-for-age Z-score (WAZ) scores were calculated based on the 2006 World Health Organization (WHO) standards. The mean of the 2006 population standards is 0. Lower standard deviations = worse outcomes. A cutoff of \\< -2 means moderately underweight (WAZ). A cutoff of \\< -3 means severely underweight (WAZ).', 'unitOfMeasure': 'Z score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In Amoxicillin, Azithromycin, Cotrimoxazole households, children assigned to receive antibiotic and placebo were analyzed separately, showed in different row below.'}, {'type': 'SECONDARY', 'title': 'Mid-upper Arm Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, twice a day as is:\n\nAmoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5 Amoxicillin Households - Antibiotic: Children in this arm will receive Amoxicillin twice a day.'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nAzithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5 Azithromycin Households - Antibiotic: Children in this arm will receive Azithromycin once a day.'}, {'id': 'OG002', 'title': 'Cotrimoxazole', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nCo-trimoxazole: 240 mg daily for Days 1-5 Cotrimoxazole: Children in this arm will receive co-trimoxazole once a day.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. In placebo households, both children received placebo.'}], 'classes': [{'title': 'Children who received Antibiotic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.01', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '14.53', 'spread': '1.11', 'groupId': 'OG001'}, {'value': '15.49', 'spread': '0.98', 'groupId': 'OG002'}]}]}, {'title': 'Children who received Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.90', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '15.15', 'spread': '1.01', 'groupId': 'OG001'}, {'value': '14.83', 'spread': '1.36', 'groupId': 'OG002'}, {'value': '15.23', 'spread': '1.23', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 35', 'description': 'Nutritional status as determined by mid-upper arm circumference in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Mid-upper arm circumference (MUAC) in each antibiotic group compared with placebo 4 weeks after last antibiotic dose.\n\nMUAC is a measure to assess nutritional status. It is measured on a straight left arm, mid-way between the tip of the shoulder and the tip of the elbow. It identifies acute malnutrition and is commonly used in children 6-59 months of age as well as pregnant women. MUAC less than 115 mm indicates severe wasting or severe acute malnutrition (SAM). MUAC greater than or equal to 115 mm and less than 125 mm indicates moderate wasting or moderate acute malnutrition (MAM).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In Amoxicillin, Azithromycin, Cotrimoxazole households, children assigned to receive antibiotic and placebo were analyzed separately, showed in different row below.'}, {'type': 'SECONDARY', 'title': "Shannon's Index of Diversity (Alpha Diversity) in Intestinal Microbiome", 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving Amoxicillin versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.\n\nChildren will receive treatment everyday, twice a day as is:\n\nAmoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5\n\nAmoxicillin: Children in this arm will receive Amoxicillin twice a day.'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving Azithromycin versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm and treated for 5 days.\n\nChildren will receive treatment everyday, once a day as is:\n\nAzithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5\n\nAzithromycin: Children in this arm will receive Azithromycin once a day.'}, {'id': 'OG002', 'title': 'Cotrimoxazole', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving Cotri-moxazole versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.\n\nChildren will receive treatment everyday, once a day as is:\n\nCo-trimoxazole: 240 mg daily for Days 1-5\n\nCotrimoxazole: Children in this arm will receive co-trimoxazole once a day.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving placebo versus children receiving antibiotics Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.\n\nChildren will receive Placebo everyday, once a day.\n\nPlacebo: Children in this arm will receive Placebo once a day.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000', 'lowerLimit': '14.5', 'upperLimit': '18.7'}, {'value': '14.6', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '16.2'}, {'value': '15.6', 'groupId': 'OG002', 'lowerLimit': '13.4', 'upperLimit': '17.8'}, {'value': '15.4', 'groupId': 'OG003', 'lowerLimit': '14.1', 'upperLimit': '16.7'}]}]}, {'title': 'Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '15.8'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '12.7'}, {'value': '13.5', 'groupId': 'OG002', 'lowerLimit': '11.6', 'upperLimit': '15.4'}, {'value': '16.0', 'groupId': 'OG003', 'lowerLimit': '14.3', 'upperLimit': '17.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 9 (Post- Treatment)', 'description': "Shannon's Alpha Diversity at Baseline and Post-treatment. combines richness and diversity. Shannon's index of diversity (alpha diversity) measures both the number of species and the inequality between species abundances. A large value is given by the presence of many species with well balanced abundances.", 'unitOfMeasure': 'Index score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '248 children in 124 households were enrolled and randomized to 1 of the 3 antibiotic regimens or placebo. Of these, 124 children were randomized within their household to receive treatment and are included in this analysis. Of these children, 9 children were lost to follow-up.\n\nThe samples for children who received placebo in Amoxicillin Households, Azithromycin Households, Cotrimoxazole Households and half of placebo (31 participants) were not collected and analyzed, due to limited budget.'}, {'type': 'SECONDARY', 'title': "Shannon's Index of Diversity (Alpha Diversity) in Nasopharyngeal Microbiome", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin Households', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, twice a day as is:\n\nAmoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5\n\nAmoxicillin Households - Antibiotic: Children in this arm will receive Amoxicillin twice a day.'}, {'id': 'OG001', 'title': 'Azithromycin Households', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nAzithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5\n\nAzithromycin Households - Antibiotic: Children in this arm will receive Azithromycin once a day.'}, {'id': 'OG002', 'title': 'Cotrimoxazole Households', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nCo-trimoxazole: 240 mg daily for Days 1-5\n\nCotrimoxazole: Children in this arm will receive co-trimoxazole once a day.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. In placebo households, both children received placebo.'}], 'timeFrame': 'Day 9', 'description': "Direct and indirect effects of antibiotics on Shannon's index of bacterial diversity", 'reportingStatus': 'POSTED', 'populationDescription': 'Nasopharyngeal samples were not analyzed, due to limited budget - samples were collected but not analyzed and never will be analyzed'}, {'type': 'SECONDARY', 'title': 'L1-norm Distance on Bacterial Reads (Intestinal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving Amoxicillin versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.\n\nChildren will receive treatment everyday, twice a day as is:\n\nAmoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5\n\nAmoxicillin: Children in this arm will receive Amoxicillin twice a day.'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving Azithromycin versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm and treated for 5 days.\n\nChildren will receive treatment everyday, once a day as is:\n\nAzithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5\n\nAzithromycin: Children in this arm will receive Azithromycin once a day.'}, {'id': 'OG002', 'title': 'Cotrimoxazole', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving Cotri-moxazole versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.\n\nChildren will receive treatment everyday, once a day as is:\n\nCo-trimoxazole: 240 mg daily for Days 1-5\n\nCotrimoxazole: Children in this arm will receive co-trimoxazole once a day.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving placebo versus children receiving antibiotics Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.\n\nChildren will receive Placebo everyday, once a day.\n\nPlacebo: Children in this arm will receive Placebo once a day.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000', 'lowerLimit': '14.5', 'upperLimit': '18.7'}, {'value': '14.6', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '16.2'}, {'value': '15.6', 'groupId': 'OG002', 'lowerLimit': '13.4', 'upperLimit': '17.8'}, {'value': '15.4', 'groupId': 'OG003', 'lowerLimit': '14.1', 'upperLimit': '16.7'}]}]}, {'title': 'Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '15.8'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '12.7'}, {'value': '13.5', 'groupId': 'OG002', 'lowerLimit': '11.6', 'upperLimit': '15.4'}, {'value': '16.0', 'groupId': 'OG003', 'lowerLimit': '14.3', 'upperLimit': '17.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 9 (Post- Treatment)', 'description': "L1-norm distance on bacterial reads (intestinal) - L1 norm is equivalent to Shannon's diversity. Shannon's Alpha Diversity combines richness and diversity. Shannon's index of diversity (alpha diversity) measures both the number of species and the inequality between species abundances. A large value is given by the presence of many species with well balanced abundances.", 'unitOfMeasure': 'Index score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '248 children in 124 households were enrolled and randomized to 1 of the 3 antibiotic regimens or placebo. Of these, 124 children were randomized within their household to receive treatment and are included in this analysis. Of these children, 9 children were lost to follow-up.\n\nThe samples for children who received placebo in Amoxicillin Households, Azithromycin Households, Cotrimoxazole Households and half of placebo (31 participants) were not collected and analyzed, due to limited budget.'}, {'type': 'SECONDARY', 'title': 'L1-norm Distance on Bacterial Reads (Nasopharyngeal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin Households', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, twice a day as is:\n\nAmoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5\n\nAmoxicillin Households - Antibiotic: Children in this arm will receive Amoxicillin twice a day.'}, {'id': 'OG001', 'title': 'Azithromycin Households', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nAzithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5\n\nAzithromycin Households - Antibiotic: Children in this arm will receive Azithromycin once a day.'}, {'id': 'OG002', 'title': 'Cotrimoxazole Households', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nCo-trimoxazole: 240 mg daily for Days 1-5\n\nCotrimoxazole: Children in this arm will receive co-trimoxazole once a day.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. In placebo households, both children received placebo.'}], 'timeFrame': 'Day 9', 'description': 'L1-norm distance on bacterial reads (nasopharyngeal)', 'reportingStatus': 'POSTED', 'populationDescription': 'Nasopharyngeal samples were not analyzed due to limited budget- samples were collected but not analyzed and never will be analyzed'}, {'type': 'SECONDARY', 'title': 'L2-norm Distance on Bacterial Reads (Intestinal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving Amoxicillin versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.\n\nChildren will receive treatment everyday, twice a day as is:\n\nAmoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5\n\nAmoxicillin: Children in this arm will receive Amoxicillin twice a day.'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving Azithromycin versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm and treated for 5 days.\n\nChildren will receive treatment everyday, once a day as is:\n\nAzithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5\n\nAzithromycin: Children in this arm will receive Azithromycin once a day.'}, {'id': 'OG002', 'title': 'Cotrimoxazole', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving Cotri-moxazole versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.\n\nChildren will receive treatment everyday, once a day as is:\n\nCo-trimoxazole: 240 mg daily for Days 1-5\n\nCotrimoxazole: Children in this arm will receive co-trimoxazole once a day.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving placebo versus children receiving antibiotics Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.\n\nChildren will receive Placebo everyday, once a day.\n\nPlacebo: Children in this arm will receive Placebo once a day.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '11.5'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '10.1'}, {'value': '9.7', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '11.2'}, {'value': '9.6', 'groupId': 'OG003', 'lowerLimit': '8.6', 'upperLimit': '10.7'}]}]}, {'title': 'Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '9.6'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '7.8'}, {'value': '8.3', 'groupId': 'OG002', 'lowerLimit': '6.9', 'upperLimit': '9.7'}, {'value': '9.8', 'groupId': 'OG003', 'lowerLimit': '8.7', 'upperLimit': '10.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 9 (Post- Treatment)', 'description': "L2-norm distance on bacterial reads (intestinal) - L2 norm is equivalent to Simpson's diversity. Simpson's Alpha Diversity were obtained at Baseline and Post-treatment in this study. The minimum of Simpson's index of diversity is 0, there is no maximum. Higher Simpson's index of diversity means more diverse. There are no subscales.", 'unitOfMeasure': 'Index score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '248 children in 124 households were enrolled and randomized to 1 of the 3 antibiotic regimens or placebo. Of these, 124 children were randomized within their household to receive treatment and are included in this analysis. Of these children, 9 children were lost to follow-up.\n\nIndirect effect (antibiotic household - placebo) was not analyzed. we will not analyzed these biological specimens because no funding are available for this. Only direct effect of treatment is analyzed.'}, {'type': 'SECONDARY', 'title': 'L2-norm Distance on Bacterial Reads (Nasopharyngeal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin Households', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, twice a day as is:\n\nAmoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5\n\nAmoxicillin Households - Antibiotic: Children in this arm will receive Amoxicillin twice a day.'}, {'id': 'OG001', 'title': 'Azithromycin Households', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nAzithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5\n\nAzithromycin Households - Antibiotic: Children in this arm will receive Azithromycin once a day.'}, {'id': 'OG002', 'title': 'Cotrimoxazole Households', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nCo-trimoxazole: 240 mg daily for Days 1-5\n\nCotrimoxazole: Children in this arm will receive co-trimoxazole once a day.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. In placebo households, both children received placebo.'}], 'timeFrame': 'Day 9', 'description': 'L2-norm distance on bacterial reads (nasopharyngeal)', 'reportingStatus': 'POSTED', 'populationDescription': "Nasopharyngeal samples were not analyzed due to limited budget. these samples were collected but won't be analyzed."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Macrolide Resistance Genes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin Households', 'description': "Eligible households that agreed to participate were randomized in a 1:1:1:1 fashion to a 5day course of amoxicillin, azithromycin, cotrimoxazole or placebo. Within each household, one child was randomized to the household's antibiotic assignment and one child to placebo. This group included children randomized to placebo in azithromycin households."}, {'id': 'OG001', 'title': 'Placebo Households', 'description': "Eligible households that agreed to participate were randomized in a 1:1:1:1 fashion to a 5day course of amoxicillin, azithromycin, cotrimoxazole or placebo. Within each household, one child was randomized to the household's antibiotic assignment and one child to placebo. In placebo households, both children received placebo, and one child was randomly assigned to serve as the control for the antibiotic-treated child in the antibiotic households and one as the control for the placebo-treated child in the antibiotic households. This group included the placebo-treated child control in placebo households."}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Prevalence of macrolide resistance genes measured using DNA-seq from rectal swabs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome is limited to children randomized to placebo in azithromycin households and to the placebo-treated child control in placebo households. A direct effect of antibiotics on the resistome was only observed among children receiving azithromycin compared with placebo; we were unable to process samples from the other study arms due to cost constraints.\n\nAccording to study design, only placebo treated children in these two arms were analyzed.'}, {'type': 'SECONDARY', 'title': 'Alpha Diversity in the Intestinal Microbiome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin Households', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, twice a day as is:\n\nAmoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5\n\nAmoxicillin Households - Antibiotic: Children in this arm will receive Amoxicillin twice a day.'}, {'id': 'OG001', 'title': 'Azithromycin Households', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nAzithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5\n\nAzithromycin Households - Antibiotic: Children in this arm will receive Azithromycin once a day.'}, {'id': 'OG002', 'title': 'Cotrimoxazole Households', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nCo-trimoxazole: 240 mg daily for Days 1-5\n\nCotrimoxazole: Children in this arm will receive co-trimoxazole once a day.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. In placebo households, both children received placebo.'}], 'timeFrame': '2 years', 'description': 'Alpha diversity in the intestinal microbiome using DNA-seq from rectal swabs', 'reportingStatus': 'POSTED', 'populationDescription': 'The intestinal microbiome in rectal swabs were not analyzed due to limited budget. these samples were collected but will not be analyzed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amoxicillin Households', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, twice a day as is:\n\nAmoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5\n\nAmoxicillin Households - Antibiotic: Children in this arm will receive Amoxicillin twice a day.'}, {'id': 'FG001', 'title': 'Azithromycin Households', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nAzithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5\n\nAzithromycin Households - Antibiotic: Children in this arm will receive Azithromycin once a day.'}, {'id': 'FG002', 'title': 'Cotrimoxazole Households', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nCo-trimoxazole: 240 mg daily for Days 1-5\n\nCotrimoxazole: Children in this arm will receive co-trimoxazole once a day.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. In placebo households, both children received placebo.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '31', 'numSubjects': '62'}, {'groupId': 'FG001', 'numUnits': '31', 'numSubjects': '62'}, {'groupId': 'FG002', 'numUnits': '31', 'numSubjects': '62'}, {'groupId': 'FG003', 'numUnits': '31', 'numSubjects': '62'}]}, {'type': 'Receive Antibiotic', 'achievements': [{'groupId': 'FG000', 'numUnits': '31', 'numSubjects': '31'}, {'groupId': 'FG001', 'numUnits': '31', 'numSubjects': '31'}, {'groupId': 'FG002', 'numUnits': '31', 'numSubjects': '31'}, {'groupId': 'FG003', 'numUnits': '31', 'numSubjects': '31'}]}, {'type': 'Receive Placebo', 'achievements': [{'groupId': 'FG000', 'numUnits': '31', 'numSubjects': '31'}, {'groupId': 'FG001', 'numUnits': '31', 'numSubjects': '31'}, {'groupId': 'FG002', 'numUnits': '31', 'numSubjects': '31'}, {'groupId': 'FG003', 'numUnits': '31', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '30', 'numSubjects': '57'}, {'groupId': 'FG001', 'numUnits': '31', 'numSubjects': '58'}, {'groupId': 'FG002', 'numUnits': '31', 'numSubjects': '56'}, {'groupId': 'FG003', 'numUnits': '31', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '5'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '4'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '6'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Had invalid anthropometric measurements', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'typeUnitsAnalyzed': 'household'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '62', 'groupId': 'BG006'}, {'value': '248', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Amoxicillin Households - Antibiotic', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, twice a day as is:\n\nAmoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5\n\nAmoxicillin Households - Antibiotic: Children in this arm will receive Amoxicillin twice a day.'}, {'id': 'BG001', 'title': 'Amoxicillin Households - Placebo', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nAmoxicillin Households - Placebo: Children in this arm will receive Placebo.'}, {'id': 'BG002', 'title': 'Azithromycin Households - Antibiotic', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nAzithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5\n\nAzithromycin Households - Antibiotic: Children in this arm will receive Azithromycin once a day.'}, {'id': 'BG003', 'title': 'Azithromycin Households - Placebo', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nAzithromycin Households - Placebo: Children in this arm will receive Placebo.'}, {'id': 'BG004', 'title': 'Cotrimoxazole Households - Antibiotic', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nChildren will receive treatment everyday, once a day as is:\n\nCo-trimoxazole: 240 mg daily for Days 1-5\n\nCotrimoxazole: Children in this arm will receive co-trimoxazole once a day.'}, {'id': 'BG005', 'title': 'Cotrimoxazole Households - Placebo', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo.\n\nCotrimoxazole Households - Placebo: Children in this arm will receive Placebo.'}, {'id': 'BG006', 'title': 'Placebo', 'description': 'Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. In placebo households, both children received placebo.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '62', 'groupId': 'BG006'}, {'value': '248', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '52'}, {'value': '36', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '53'}, {'value': '29', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '51'}, {'value': '42', 'groupId': 'BG003', 'lowerLimit': '30', 'upperLimit': '47'}, {'value': '37', 'groupId': 'BG004', 'lowerLimit': '23', 'upperLimit': '48'}, {'value': '40', 'groupId': 'BG005', 'lowerLimit': '23', 'upperLimit': '50'}, {'value': '38', 'groupId': 'BG006', 'lowerLimit': '30', 'upperLimit': '49'}, {'value': '37', 'groupId': 'BG007', 'lowerLimit': '25', 'upperLimit': '49'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '62', 'groupId': 'BG006'}, {'value': '248', 'groupId': 'BG007'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '125', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '38', 'groupId': 'BG006'}, {'value': '123', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Wasted', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '62', 'groupId': 'BG006'}, {'value': '248', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Defined as Weight-for-height Z-score (WHZ) \\< -2 SD.', 'unitOfMeasure': 'Participants'}, {'title': 'Stunted', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '62', 'groupId': 'BG006'}, {'value': '248', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '52', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Defined as Height-for-age Z-score (HAZ) \\< -2 SD.', 'unitOfMeasure': 'Participants'}, {'title': 'Underweight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '62', 'groupId': 'BG006'}, {'value': '248', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '35', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Defined as Weight-for-age Z-score (WAZ) \\< -2 SD.', 'unitOfMeasure': 'Participants'}, {'title': 'Visited healthcare facility in past 30 days', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '62', 'groupId': 'BG006'}, {'value': '248', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '42', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Children between 6 and 59 months of age and with parental consent. Data were only collected from children. In each arm, one children was given Antibiotic and one children was given Placebo. The baseline characteristics were reported separately in analysis and papers.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-19', 'size': 2959494, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-17T17:26', 'hasProtocol': True}, {'date': '2017-06-01', 'size': 80054, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-17T12:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Households will be randomized to one of four treatment arms (azithromycin, cotrimoxazole, amoxicillin, or placebo), and each child age 6-59 months in the household will receive 5 days of treatment. One child within each of the antibiotic households will be randomly selected to receive placebo instead of the antibiotc, to allow for study of indirect effects of antibiotic use'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'dispFirstSubmitDate': '2020-07-31', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-01', 'studyFirstSubmitDate': '2017-06-12', 'dispFirstSubmitQcDate': '2023-02-01', 'resultsFirstSubmitDate': '2021-09-17', 'studyFirstSubmitQcDate': '2017-06-13', 'dispFirstPostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-01', 'studyFirstPostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Simpson's Index of Diversity (Alpha Diversity) in Intestinal Microbiome", 'timeFrame': 'Baseline and Day 9', 'description': "The primary outcome of the study was pre-specified as α-diversity (inverse Simpson's) at the genus level, expressed in effective number. Simpson's Alpha Diversity were obtained at Baseline and Post-treatment in this study. The minimum of Simpson's index of diversity is 0, there is no maximum. Higher Simpson's index of diversity means more diverse. There are no subscales."}], 'secondaryOutcomes': [{'measure': "Simpson's Index of Diversity (Alpha Diversity) in Microbiome", 'timeFrame': 'Day 9', 'description': 'Direct and indirect effect of antibiotics on alpha diversity from rectal samples'}, {'measure': 'Weight-for-height Z-score', 'timeFrame': 'Day 35', 'description': 'Nutritional status as determined by weight-for-height Z-score vs. Placebo household Weight-for-height Z-score in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Weight-for-height Z (WHZ) scores were calculated based on the 2006 World Health Organization (WHO) standards. The mean of the 2006 population standards is 0. Lower standard deviations = worse outcomes. A cutoff of \\< -2 means moderately wasted (WHZ). A cutoff of \\< -3 means wasted (WHZ).'}, {'measure': 'Height-for-age Z-score', 'timeFrame': 'Day 35', 'description': 'Nutritional status as determined by height-for-age Z-score Height-for-age Z-score in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Height-for-age Z (HAZ) score were calculated based on the 2006 World Health Organization (WHO) standards. The mean of the 2006 population standards is 0. Lower standard deviations = worse outcomes. A cutoff of \\< -2 means moderately stunted (HAZ). A cutoff of \\< -3 means severely stunted (HAZ).'}, {'measure': 'Weight-for-age Z-score', 'timeFrame': 'Day 35', 'description': 'Nutritional status as determined by weight-for-age Z-score vs. Placebo household Weight-for-age Z-score in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Weight-for-age Z-score (WAZ) scores were calculated based on the 2006 World Health Organization (WHO) standards. The mean of the 2006 population standards is 0. Lower standard deviations = worse outcomes. A cutoff of \\< -2 means moderately underweight (WAZ). A cutoff of \\< -3 means severely underweight (WAZ).'}, {'measure': 'Mid-upper Arm Circumference', 'timeFrame': 'Day 35', 'description': 'Nutritional status as determined by mid-upper arm circumference in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Mid-upper arm circumference (MUAC) in each antibiotic group compared with placebo 4 weeks after last antibiotic dose.\n\nMUAC is a measure to assess nutritional status. It is measured on a straight left arm, mid-way between the tip of the shoulder and the tip of the elbow. It identifies acute malnutrition and is commonly used in children 6-59 months of age as well as pregnant women. MUAC less than 115 mm indicates severe wasting or severe acute malnutrition (SAM). MUAC greater than or equal to 115 mm and less than 125 mm indicates moderate wasting or moderate acute malnutrition (MAM).'}, {'measure': "Shannon's Index of Diversity (Alpha Diversity) in Intestinal Microbiome", 'timeFrame': 'Baseline and Day 9 (Post- Treatment)', 'description': "Shannon's Alpha Diversity at Baseline and Post-treatment. combines richness and diversity. Shannon's index of diversity (alpha diversity) measures both the number of species and the inequality between species abundances. A large value is given by the presence of many species with well balanced abundances."}, {'measure': "Shannon's Index of Diversity (Alpha Diversity) in Nasopharyngeal Microbiome", 'timeFrame': 'Day 9', 'description': "Direct and indirect effects of antibiotics on Shannon's index of bacterial diversity"}, {'measure': 'L1-norm Distance on Bacterial Reads (Intestinal)', 'timeFrame': 'Baseline and Day 9 (Post- Treatment)', 'description': "L1-norm distance on bacterial reads (intestinal) - L1 norm is equivalent to Shannon's diversity. Shannon's Alpha Diversity combines richness and diversity. Shannon's index of diversity (alpha diversity) measures both the number of species and the inequality between species abundances. A large value is given by the presence of many species with well balanced abundances."}, {'measure': 'L1-norm Distance on Bacterial Reads (Nasopharyngeal)', 'timeFrame': 'Day 9', 'description': 'L1-norm distance on bacterial reads (nasopharyngeal)'}, {'measure': 'L2-norm Distance on Bacterial Reads (Intestinal)', 'timeFrame': 'Baseline and Day 9 (Post- Treatment)', 'description': "L2-norm distance on bacterial reads (intestinal) - L2 norm is equivalent to Simpson's diversity. Simpson's Alpha Diversity were obtained at Baseline and Post-treatment in this study. The minimum of Simpson's index of diversity is 0, there is no maximum. Higher Simpson's index of diversity means more diverse. There are no subscales."}, {'measure': 'L2-norm Distance on Bacterial Reads (Nasopharyngeal)', 'timeFrame': 'Day 9', 'description': 'L2-norm distance on bacterial reads (nasopharyngeal)'}, {'measure': 'Number of Participants With Macrolide Resistance Genes', 'timeFrame': '2 years', 'description': 'Prevalence of macrolide resistance genes measured using DNA-seq from rectal swabs.'}, {'measure': 'Alpha Diversity in the Intestinal Microbiome', 'timeFrame': '2 years', 'description': 'Alpha diversity in the intestinal microbiome using DNA-seq from rectal swabs'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infection', 'azithromycin', 'amoxicillin', 'co-trimoxazole', 'trachoma', 'mass treatment'], 'conditions': ['Child Development']}, 'referencesModule': {'references': [{'pmid': '32556194', 'type': 'DERIVED', 'citation': 'Oldenburg CE, Hinterwirth A, Worden L, Sie A, Dah C, Ouermi L, Coulibaly B, Zhong L, Chen C, Ruder K, Lietman TM, Keenan JD, Doan T. Indirect effect of oral azithromycin on the gut resistome of untreated children: a randomized controlled trial. Int Health. 2021 Feb 24;13(2):130-134. doi: 10.1093/inthealth/ihaa029.'}, {'pmid': '31362969', 'type': 'DERIVED', 'citation': "Dennis EG, Sie A, Ouermi L, Dah C, Tapsoba C, Zabre P, Barnighausen T, O'Brien KS, Lebas E, Keenan JD, Oldenburg CE. Short-term weight gain among preschool children in rural Burkina Faso: a secondary analysis of a randomised controlled trial. BMJ Open. 2019 Jul 29;9(7):e029634. doi: 10.1136/bmjopen-2019-029634."}, {'pmid': '30895203', 'type': 'DERIVED', 'citation': 'Oldenburg CE, Sie A, Coulibaly B, Ouermi L, Dah C, Tapsoba C, Barnighausen T, Lebas E, Arzika AM, Cummings S, Zhong L, Lietman TM, Keenan JD, Doan T. Indirect Effect of Azithromycin Use on the Intestinal Microbiome Diversity of Untreated Children: A Randomized Trial. Open Forum Infect Dis. 2019 Feb 6;6(3):ofz061. doi: 10.1093/ofid/ofz061. eCollection 2019 Mar.'}, {'pmid': '30515431', 'type': 'DERIVED', 'citation': 'Oldenburg CE, Sie A, Coulibaly B, Ouermi L, Dah C, Tapsoba C, Barnighausen T, Ray KJ, Zhong L, Cummings S, Lebas E, Lietman TM, Keenan JD, Doan T. Effect of Commonly Used Pediatric Antibiotics on Gut Microbial Diversity in Preschool Children in Burkina Faso: A Randomized Clinical Trial. Open Forum Infect Dis. 2018 Nov 2;5(11):ofy289. doi: 10.1093/ofid/ofy289. eCollection 2018 Nov.'}, {'pmid': '30014828', 'type': 'DERIVED', 'citation': 'Sie A, Dah C, Ouermi L, Tapsoba C, Zabre P, Barnighausen T, Lebas E, Arzika AM, Snyder BM, Porco TC, Lietman TM, Keenan JD, Oldenburg CE. Effect of Antibiotics on Short-Term Growth among Children in Burkina Faso: A Randomized Trial. Am J Trop Med Hyg. 2018 Sep;99(3):789-796. doi: 10.4269/ajtmh.18-0342. Epub 2018 Jul 12.'}]}, 'descriptionModule': {'briefSummary': 'The use of antibiotics has saved millions of human lives, however consumption of antibiotics can select for antibiotic resistant organisms and may lead to changes in commensal microbiome. This study is designed to estimate the effect of antibiotic consumption on microbiome in a rural region of rural Burkina Faso. Changes in the intestinal and nasopharyngeal microbiome and resistome following a short course of antibiotics will be measured.', 'detailedDescription': 'This study is designed to better understand the effect of a short course of antibiotics on changes in intestinal and nasopharyngeal microbiome on treated children and untreated household contacts. The investigators hypothesize that a short course of antibiotics will lead to decreased bacterial diversity shortly after completion of the antibiotic course, and higher probability of identification of bacterial resistance genes in rectal and nasopharyngeal samples. The investigators hypothesize that a 5-day course of antibiotics (azithromycin, amoxicillin, or co-trimoxazole) will lead to significantly decreased intestinal and nasopharyngeal bacterial diversity among children aged 6-59 months.\n\nSpecific Aim 1. Determine the effect of treatment with antibiotics on microbiome diversity in children aged 6-59 months following a 5-day course of antibiotics.\n\nSpecific Aim 1A. Determine the direct effect of a 5-day course of azithromycin, amoxicillin, or co-trimoxazole on intestinal and nasopharyngeal bacterial diversity in children aged 6-59 months compared to no treatment.\n\nSpecific Aim 1B. Determine the indirect effect of antibiotic treatment of children in a household on intestinal and nasopharyngeal bacterial diversity in an untreated child aged 6-59 months.\n\nSpecific Aim 1C. Assess the association between intestinal bacterial diversity and anthropometry in a population-based sample of children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Households will be eligible for inclusion in the study if they have 2 or more children aged 6 months to 59 months currently residing in the household. Children from the household will be eligible if they are 6-59 months of age and are not currently receiving antibiotic treatment\n\nExclusion Criteria:\n\n* Children who are allergic to any of the study antibiotics will be excluded. Individuals aged under 6 months and 5 years or older will be excluded. Children already receiving antibiotics for an ongoing disease will be excluded.'}, 'identificationModule': {'nctId': 'NCT03187834', 'acronym': 'ARMCA', 'briefTitle': 'Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso', 'orgStudyIdInfo': {'id': '17-22036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Azithromycin', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving Azithromycin versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm and treated for 5 days.\n\nChildren will receive treatment everyday, once a day as is:\n\nAzithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5', 'interventionNames': ['Drug: Azithromycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amoxicillin', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving Amoxicillin versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.\n\nChildren will receive treatment everyday, twice a day as is:\n\nAmoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5', 'interventionNames': ['Drug: Amoxicillin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cotrimoxazole', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving Cotri-moxazole versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.\n\nChildren will receive treatment everyday, once a day as is:\n\nCo-trimoxazole: 240 mg daily for Days 1-5', 'interventionNames': ['Drug: Cotrimoxazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Comparison of nasopharyngeal and rectal microbiome in children receiving placebo versus children receiving antibiotics Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.\n\nChildren will receive Placebo everyday, once a day.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Azithromycin', 'type': 'DRUG', 'otherNames': ['Zithromax'], 'description': 'Children in this arm will receive Azithromycin once a day.', 'armGroupLabels': ['Azithromycin']}, {'name': 'Amoxicillin', 'type': 'DRUG', 'description': 'Children in this arm will receive Amoxicillin twice a day.', 'armGroupLabels': ['Amoxicillin']}, {'name': 'Cotrimoxazole', 'type': 'DRUG', 'description': 'Children in this arm will receive co-trimoxazole once a day.', 'armGroupLabels': ['Cotrimoxazole']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Children in this arm will receive Placebo once a day.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Proctor Foundation', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Nouna', 'country': 'Burkina Faso', 'facility': 'Centre de Recherche en Santé de Nouna', 'geoPoint': {'lat': 12.72939, 'lon': -3.86305}}], 'overallOfficials': [{'name': 'Thomas M Lietman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSF F.I. Proctor Foundation'}, {'name': 'Catherine E Oldenburg, ScD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UCSF F.I. Proctor Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre de Recherche en Sante de Nouna, Burkina Faso', 'class': 'OTHER_GOV'}, {'name': 'Heidelberg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}