Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-24 @ 10:20 PM
Study NCT ID:
NCT03676751
Status:
COMPLETED
Last Update Posted:
2023-08-09
First Post:
2018-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MORDOR II Burkina Faso: Longitudinal Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tom.lietman@ucsf.edu', 'phone': '(415) 476-1442', 'title': 'Pr Thomas Lietman', 'organization': 'UCSF FI Proctor'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '14 days following azithromycin or placebo treatment. Deaths were assessed up to 180 days post-treatment. Adverse Events were assessed 14 days following azithromycin or placebo treatment', 'description': 'We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.', 'eventGroups': [{'id': 'EG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.', 'otherNumAtRisk': 221, 'deathsNumAtRisk': 221, 'otherNumAffected': 44, 'seriousNumAtRisk': 221, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin', 'otherNumAtRisk': 209, 'deathsNumAtRisk': 209, 'otherNumAffected': 42, 'seriousNumAtRisk': 209, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fever (self-report)', 'notes': '14 days following azithromycin or placebo treatment among children aged 0-59 months', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'notes': '14 days following azithromycin or placebo treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'notes': '14 days following azithromycin or placebo treatment among children', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin rash', 'notes': '14 days following azithromycin or placebo treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intestinal Microbial Diversity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}], 'classes': [{'categories': [{'measurements': [{'value': '46.3', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '49.5', 'spread': '11.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': "The primary outcome of the study was pre-specified as α-diversity (inverse Simpson's) at the genus level, expressed in effective number. 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': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done 5-pooled.'}, {'type': 'PRIMARY', 'title': 'Macrolide Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}], 'classes': [{'categories': [{'measurements': [{'value': '98.89', 'spread': '184.62', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '3.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Presence of macrolide genetic resistance determinants measured using DNA-seq from rectal swabs from 450 children.\n\nMacrolide resistance is defined by resistance to erythromycin or clarithromycin.\n\nWe compare the read numbers of macrolide resistance in each treatment group. A higher read number indicates more resistance.', 'unitOfMeasure': 'number of reads', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We were able to follow up with 221 patients in the azithromycin arm and 208 children in the placebo arm.'}, {'type': 'SECONDARY', 'title': 'Change in Weight Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 days post-treatment', 'description': 'WAZ. Weight will be measured at all follow-ups and weight-for-age z-scores will be calculated. Weight measured in kg.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Height Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}], 'classes': [{'categories': [{'measurements': [{'value': '91.6', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '91.3', 'spread': '10.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 days post-treatment', 'description': 'Height or length will be measured at all follow-ups and height-for-age z-scores will be calculated.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Infantile Hypertrophic Pyloric Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days post-treatment', 'description': 'Vital status will be assessed at all follow-up time points. Mortality will be defined as death within the study period. Date of death will be collected.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Malaria Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days post-treatment', 'description': 'Number of Participants Positive for Malaria. Blood smears (thin and thick) for malaria will be collected at all follow-ups to determine malaria infection status.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days post-treatment', 'description': 'Caregivers will be asked if the child has been taken to the health post since the last visit and why', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Genotypic Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}], 'classes': [{'categories': [{'measurements': [{'value': '7547', 'groupId': 'OG000'}, {'value': '13077', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '180 days post-treatment', 'description': 'Total resistance read numbers in 12 classes: Aminoglycosides, Cationic antimicrobial peptides, Elfamycins, MLS, Metronidazole, Multi-drug resistance, Phenicol, Rifampin, Sulfonamides, Tetracyclines, Trimethoprim, and Beta-lactams.\n\nWe compare the read numbers of macrolide resistance in each treatment group. A higher read number indicates more resistance.', 'unitOfMeasure': 'number of reads', 'reportingStatus': 'POSTED', 'populationDescription': 'We were able to follow up with 200 children in the azithromycin group and 191 children in the placebo group.'}, {'type': 'SECONDARY', 'title': 'Inflammatory Marker Changes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}], 'timeFrame': '6 months', 'description': 'Measured by C-reactive protein', 'reportingStatus': 'POSTED', 'populationDescription': 'The Inflammatory marker changes data is not collected in this study'}, {'type': 'SECONDARY', 'title': 'IgA-bound Bacteria From Small Intestine Changes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}], 'timeFrame': '180 days post-treatment', 'description': 'Measured using BugFACS from whole blood and stool', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is not collected'}, {'type': 'SECONDARY', 'title': 'Nutritional Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 days post-treatment', 'description': 'To be measured using mid-upper arm circumference', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acute Modulation of the Gut Microbiome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}], 'timeFrame': '2 weeks post-treatment', 'description': 'Next generation sequencing', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected/analyzed.'}, {'type': 'SECONDARY', 'title': 'L-1 Norm Distance on Bacterial Reads (Intestinal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}], 'classes': [{'categories': [{'measurements': [{'value': '32.98', 'spread': '9.37', 'groupId': 'OG000'}, {'value': '43.15', 'spread': '12.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks post-treatment', 'description': "L-1 norm distance on bacterial reads (intestinal) from rectal swabs of 50 children. 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': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'L-2 Norm Distance on Bacterial Reads (Intestinal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}], 'classes': [{'categories': [{'measurements': [{'value': '14.81', 'spread': '5.72', 'groupId': 'OG000'}, {'value': '20.46', 'spread': '7.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks post-treatment', 'description': "L-2 norm distance on bacterial reads (intestinal) from rectal swabs of 450 children. 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': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Normalized Reads for Campylobacter Species', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}], 'classes': [{'categories': [{'measurements': [{'value': '1886.12', 'groupId': 'OG000'}, {'value': '549.48', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks post-treatment', 'description': 'Reduce in normalized reads for Campylobacter species using DNA-seq from rectal swabs of 450 children.\n\nWe compare the read numbers of Campylobacter species in each treatment group. Campylobacter is associated with disease. Reduction in Campylobacter species burden may reduce diarrhea-related mortality.', 'unitOfMeasure': 'number of reads', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Resistome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}], 'classes': [{'categories': [{'measurements': [{'value': '3.98', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '2.23', 'spread': '2.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks post-treatment', 'description': 'Chao1 total resistance gene determinant richness using DNA-seq from rectal swabs of 450 children.\n\nWe calculated Chao1 total resistance gene determinant richness across arms. Species richness is the simplest measure of biodiversity and is just a count of the number of different species in a given area.', 'unitOfMeasure': 'number of species', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '220'}]}, {'type': 'Received Allocated Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '227'}, {'groupId': 'FG001', 'numSubjects': '214'}]}, {'type': 'Week 14 Follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '218'}, {'groupId': 'FG001', 'numSubjects': '203'}]}, {'type': 'COMPLETED', 'comment': 'Month 6', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '189'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '450', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.\n\nAzithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.\n\nPlacebo: Oral suspension of placebo for azithromycin'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000', 'lowerLimit': '15', 'upperLimit': '39'}, {'value': '28', 'groupId': 'BG001', 'lowerLimit': '17', 'upperLimit': '38'}, {'value': '28', 'groupId': 'BG002', 'lowerLimit': '16', 'upperLimit': '38'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '450', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Burkina Faso', 'categories': [{'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '450', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "Mother's age", 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '32'}, {'value': '28', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '33'}, {'value': '28', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '33'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': "Mother's education", 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}, {'title': 'Primary', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Secondary or higher', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mid-upper arm circumference, cm', 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'groupId': 'BG000', 'lowerLimit': '13', 'upperLimit': '15'}, {'value': '14.4', 'groupId': 'BG001', 'lowerLimit': '13.5', 'upperLimit': '15'}, {'value': '14.3', 'groupId': 'BG002', 'lowerLimit': '13.5', 'upperLimit': '15'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Weight, kg', 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'groupId': 'BG000', 'lowerLimit': '8.8', 'upperLimit': '13.5'}, {'value': '11.5', 'groupId': 'BG001', 'lowerLimit': '9.4', 'upperLimit': '13.4'}, {'value': '11.4', 'groupId': 'BG002', 'lowerLimit': '9.0', 'upperLimit': '13.4'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Height, cm', 'classes': [{'categories': [{'measurements': [{'value': '85.3', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '85.4', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '85.4', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight-for-height Z-score', 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '-0.4', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '-0.5', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', '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': 'score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height-for-age Z-score', 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '-0.8', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '-0.9', 'spread': '1.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', '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': 'score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight-for-age Z-score', 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '-0.7', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '-0.9', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', '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': 'score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Wasted (WHZ < -2)', 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stunted (HAZ < -2)', 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Underweight (WAZ < -2)', 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mid-upper arm circumference < 12.5 cm', 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Malaria RDT Positive', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-01', 'size': 1331447, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-01-06T18:59', 'hasProtocol': True}, {'date': '2021-10-20', 'size': 140061, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-01-06T18:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Quadruple: (Participant, Care Provider, Investigator, Outcomes Assessor)'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Individually randomized placebo-controlled trail of azithromycin vs. placebo to establish the efficacy and safety of azithromycin.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'dispFirstSubmitDate': '2021-03-16', 'completionDateStruct': {'date': '2020-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-20', 'studyFirstSubmitDate': '2018-09-17', 'resultsFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2018-09-17', 'dispFirstPostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-20', 'studyFirstPostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intestinal Microbial Diversity', 'timeFrame': '6 months', 'description': "The primary outcome of the study was pre-specified as α-diversity (inverse Simpson's) at the genus level, expressed in effective number. 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': 'Macrolide Resistance', 'timeFrame': '2 weeks', 'description': 'Presence of macrolide genetic resistance determinants measured using DNA-seq from rectal swabs from 450 children.\n\nMacrolide resistance is defined by resistance to erythromycin or clarithromycin.\n\nWe compare the read numbers of macrolide resistance in each treatment group. A higher read number indicates more resistance.'}], 'secondaryOutcomes': [{'measure': 'Change in Weight Over Time', 'timeFrame': '180 days post-treatment', 'description': 'WAZ. Weight will be measured at all follow-ups and weight-for-age z-scores will be calculated. Weight measured in kg.'}, {'measure': 'Change in Height Over Time', 'timeFrame': '180 days post-treatment', 'description': 'Height or length will be measured at all follow-ups and height-for-age z-scores will be calculated.'}, {'measure': 'Number of Participants With Infantile Hypertrophic Pyloric Stenosis', 'timeFrame': '6 months'}, {'measure': 'Mortality', 'timeFrame': '180 days post-treatment', 'description': 'Vital status will be assessed at all follow-up time points. Mortality will be defined as death within the study period. Date of death will be collected.'}, {'measure': 'Malaria Status', 'timeFrame': '180 days post-treatment', 'description': 'Number of Participants Positive for Malaria. Blood smears (thin and thick) for malaria will be collected at all follow-ups to determine malaria infection status.'}, {'measure': 'Adverse Events', 'timeFrame': '14 days post-treatment', 'description': 'Caregivers will be asked if the child has been taken to the health post since the last visit and why'}, {'measure': 'Genotypic Resistance', 'timeFrame': '180 days post-treatment', 'description': 'Total resistance read numbers in 12 classes: Aminoglycosides, Cationic antimicrobial peptides, Elfamycins, MLS, Metronidazole, Multi-drug resistance, Phenicol, Rifampin, Sulfonamides, Tetracyclines, Trimethoprim, and Beta-lactams.\n\nWe compare the read numbers of macrolide resistance in each treatment group. A higher read number indicates more resistance.'}, {'measure': 'Inflammatory Marker Changes', 'timeFrame': '6 months', 'description': 'Measured by C-reactive protein'}, {'measure': 'IgA-bound Bacteria From Small Intestine Changes', 'timeFrame': '180 days post-treatment', 'description': 'Measured using BugFACS from whole blood and stool'}, {'measure': 'Nutritional Status', 'timeFrame': '180 days post-treatment', 'description': 'To be measured using mid-upper arm circumference'}, {'measure': 'Acute Modulation of the Gut Microbiome', 'timeFrame': '2 weeks post-treatment', 'description': 'Next generation sequencing'}, {'measure': 'L-1 Norm Distance on Bacterial Reads (Intestinal)', 'timeFrame': '2 weeks post-treatment', 'description': "L-1 norm distance on bacterial reads (intestinal) from rectal swabs of 50 children. 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': 'L-2 Norm Distance on Bacterial Reads (Intestinal)', 'timeFrame': '2 weeks post-treatment', 'description': "L-2 norm distance on bacterial reads (intestinal) from rectal swabs of 450 children. 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': 'Changes in Normalized Reads for Campylobacter Species', 'timeFrame': '2 weeks post-treatment', 'description': 'Reduce in normalized reads for Campylobacter species using DNA-seq from rectal swabs of 450 children.\n\nWe compare the read numbers of Campylobacter species in each treatment group. Campylobacter is associated with disease. Reduction in Campylobacter species burden may reduce diarrhea-related mortality.'}, {'measure': 'Resistome', 'timeFrame': '2 weeks post-treatment', 'description': 'Chao1 total resistance gene determinant richness using DNA-seq from rectal swabs of 450 children.\n\nWe calculated Chao1 total resistance gene determinant richness across arms. Species richness is the simplest measure of biodiversity and is just a count of the number of different species in a given area.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['azithromycin', 'mass drug administration', 'childhood mortality'], 'conditions': ['Child Growth', 'Diversity of Microbiome', 'Child Mortality', 'Resistance Bacterial']}, 'referencesModule': {'references': [{'pmid': '38227963', 'type': 'DERIVED', 'citation': 'Doan T, Liu Z, Sie A, Dah C, Bountogo M, Ouattara M, Coulibaly B, Kiemde D, Zonou G, Nebie E, Brogdon J, Lebas E, Hinterwirth A, Zhong L, Chen C, Zhou Z, Porco T, Arnold BF, Oldenburg CE, Lietman TM. Gut Microbiome Diversity and Antimicrobial Resistance After a Single Dose of Oral Azithromycin in Children: A Randomized Placebo-Controlled Trial. Am J Trop Med Hyg. 2024 Jan 16;110(2):291-294. doi: 10.4269/ajtmh.23-0651. Print 2024 Feb 7.'}, {'pmid': '35944061', 'type': 'DERIVED', 'citation': 'Coulibaly B, Kiemde D, Zonou G, Sie A, Dah C, Bountogo M, Brogdon J, Hu H, Lebas E, Porco TC, Doan T, Lietman TM, Oldenburg CE. Effect of Single-dose Azithromycin on Pneumococcal Carriage and Resistance: A Randomized Controlled Trial. Pediatr Infect Dis J. 2022 Sep 1;41(9):728-730. doi: 10.1097/INF.0000000000003585. Epub 2022 May 23.'}, {'pmid': '34465327', 'type': 'DERIVED', 'citation': 'Coulibaly B, Sie A, Dah C, Bountogo M, Ouattara M, Compaore A, Nikiema M, Tiansi JN, Sibiri ND, Brogdon JM, Lebas E, Doan T, Porco TC, Lietman TM, Oldenburg CE. Effect of a single dose of oral azithromycin on malaria parasitaemia in children: a randomized controlled trial. Malar J. 2021 Aug 31;20(1):360. doi: 10.1186/s12936-021-03895-9.'}, {'pmid': '33731058', 'type': 'DERIVED', 'citation': 'Sie A, Coulibaly B, Dah C, Bountogo M, Ouattara M, Compaore G, Brogdon JM, Godwin WW, Lebas E, Doan T, Arnold BF, Porco TC, Lietman TM, Oldenburg CE. Single-dose azithromycin for child growth in Burkina Faso: a randomized controlled trial. BMC Pediatr. 2021 Mar 17;21(1):130. doi: 10.1186/s12887-021-02601-7.'}]}, 'descriptionModule': {'briefSummary': "Globally, childhood mortality has shown a promising downward trend in recent years, however, many sub-Saharan countries still have relatively high child mortality rates. In previous studies within Niger, Tanzania, and Malawi, mass azithromycin treatment to children aged 1-59 months old effectively reduced all-cause childhood mortality. A similar study will be conducted in Burkina Faso to replicate the results of mass azithromycin treatment.\n\nThe investigators propose an individually randomized placebo-controlled trial alongside the MORDOR II Burkina Faso trial to evaluate the effect of a single dose of azithromycin (20 mg/kg) on potential mediators of the effect of azithromycin on all-cause mortality. Many questions surround the mechanism behind azithromycin's effect on reducing childhood mortality. Further questions exist regarding antibiotic resistance and how mass antibiotic administration can impact intestinal microflora. The goal of this study is to demonstrate the changes in the gut microbiome after antibiotic administration and to measure the growth of children after receiving a single dose of azithromycin. Additionally we will measure resistance markers, inflammatory markers, and IgA-bound bacteria. We hypothesize that a single dose of azithromycin will lead to a significant increase in child growth and that the gut microbiome will be significantly different in children who received azithromycin compared to those who received placebo.\n\nObjectives:\n\n1. . To determine the effect of a single dose of azithromycin for children aged 8 days-59 months on longitudinal changes in the intestinal microbiome over a 6-month period. We hypothesize that a single dose of azithromycin will result in a significant difference in the intestinal microbiome within the treatment group compared to the placebo group after a 6-month period within children ages 8 days-59 months.\n2. . To determine the effect of a single dose of azithromycin for children aged 8 days-59 months on child growth over a 6-month period. We hypothesize that a single dose of azithromycin will increase child growth over a 6-month period in children aged 8 days-59 months.\n3. . To determine the effect of a single dose of azithromycin for children aged 8 days to 59 months on the presence of macrolide genetic resistance determinants within the first two weeks post-treatment. The investigators hypothesize that a single dose of azithromycin will increase the presence of macrolide resistance determinants over a 2 week period in children aged 8 days to 59 months.\n\nThe study will be conducted in Nouna Town in northwestern Burkina Faso.", 'detailedDescription': "The investigators' previous MORDOR I research demonstrated a significant reduction in all-cause child mortality after biannual mass azithromycin distribution. In three sub-Saharan Africa countries, (including Niger, Tanzania, and Malawi) mass azithromycin treatment over 2 years resulted in a 14% reduction in child mortality. Moreover, 1 in 5-6 deaths were shown to be averted within Niger alone1. Similar findings were demonstrated in a previous study for trachoma control in Ethiopia with mass azithromycin distribution. This study in rural Ethiopia noted a nearly 50% decrease in all-cause childhood mortality5. However, neither of these studies evaluated the longitudinal impact azithromycin has on the gut microbiome. The MORDOR II trial in Burkina Faso will further evaluate the efficacy of biannual azithromycin treatment. The under-5 child mortality rate in Burkina Faso is approximately 110 per 1,000 live births. Major causes of child mortality in this area are infectious mostly due to malaria, diarrhea, and upper respiratory tract infections. In addition, malnutrition contributes to a high burden of child mortality and morbidity within this region as well. By treating underlying conditions, the use of routine antibiotic treatment could reduce diverse health outcomes leading to morbidity and mortality. The investigative team proposes to conduct this study alongside the MORDOR II trial in the town of Nouna where a majority of childhood deaths are attributable to infectious causes and malnutrition.\n\nThe World Health Organization is considering adopting the presumptive use of azithromycin and other antibiotics as a recommendation to reduce childhood mortality in areas with a high infectious disease burden2. Many questions remain unanswered surrounding the use of mass antibiotic treatment in areas with high child morbidity and mortality. This study will add to the current knowledge of mass azithromycin distribution from our previous MORDOR I research. The investigators propose to evaluate how azithromycin will impact childhood growth and to assess the changes that occur in the intestinal microbiome following a single dose of azithromycin treatment. The goal is to contribute more scientific literature that could assist future guidelines regarding antibiotic use.\n\nThe role of antibiotics on child growth is unclear. Recent studies indicate that antibiotic use could impact child growth, but a previous study in Niger failed to find a statistically significant correlation between antibiotic treatment with azithromycin and stunting, underweight, or MUAC of pre-school aged children. Longitudinal studies have been recommended to further investigate the role of antibiotics on child growth6. Meanwhile some studies suggest antibiotics may create modifications in the gut microbiota impacting nutrient absorption and weight gain7.The investigative team proposes to measure child growth through anthropometric measurements longitudinally over a 6-month period to see if azithromycin treatment impacts child development. We hypothesize that children receiving a dose of azithromycin will have more growth and development in terms of height, weight, and mid-upper arm circumference compared to children who receive placebo.\n\nThe investigators propose a longitudinal study designed to improve our knowledge about the changes in the intestinal microbiome following the course of a single dose of antibiotic in a setting with high childhood mortality and morbidity. More specifically, we propose to follow 500 children for a 6-month time period that are between the ages of 8 days old and 59 months old. Children in this age bracket are at the highest risk for mortality from infectious causes, and furthermore, they are at the highest risk for malnutrition. This group of children would receive the greatest benefit from this intervention. The causal changes in the microbiome are vastly understudied in regards to changes in the gut microbiome following a course of antibiotics. The investigators hypothesize that children receiving a dose of azithromycin will have a higher prevalence of pneumococcal resistance in nasopharyngeal samples, decreased bacterial diversity, and a higher likelihood of identification of bacterial resistance genes in stool and nasopharyngeal samples.\n\nA small group of 50 children (25 per arm) will be followed more intensely within the first 2 weeks of treatment to evaluate macrolide resistance. The investigators hypothesize that children receiving azithromycin will have a greater presence of macrolide genetic resistant determinants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '8 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 8 days and 59 months old\n* Primary residence within catchment area of study site\n* Available for full 6 month study\n* No known allergy to macrolides/azalides\n* Appropriate written informed consent from at least one parent or guardian\n* Able to feed orally\n\nExclusion Criteria:\n\n* \\<8 days old or \\>59 months\n* Primary residence outside catchment area of study site\n* Not available for full 6 month study\n* Known allergy to macrolides/azalides\n* No written informed consent from at least one parent or guardian\n* Unable to feed orally'}, 'identificationModule': {'nctId': 'NCT03676751', 'acronym': 'GAMIN', 'briefTitle': 'MORDOR II Burkina Faso: Longitudinal Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Gut and Azithromycin Mechanisms in Infants and Neonates', 'orgStudyIdInfo': {'id': 'OPP1187628-C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Azithromycin', 'description': 'A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.', 'interventionNames': ['Drug: Azithromycin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Azithromycin', 'type': 'DRUG', 'description': 'Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.', 'armGroupLabels': ['Azithromycin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral suspension of placebo for azithromycin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nouna', 'country': 'Burkina Faso', 'facility': 'Centre de Recherche en Sante de Nouna', 'geoPoint': {'lat': 12.72939, 'lon': -3.86305}}], 'overallOfficials': [{'name': 'Catherine Oldenburg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Ali Sie, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de Recherce en Sante de Nouna'}, {'name': 'Tom Lietman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, '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': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}