Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-31 @ 12:27 PM
Study NCT ID:
NCT01486758
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2011-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'beigelman_a@kids.wustl.edu', 'phone': '314-454-2694', 'title': 'Dr. Avraham Beigelman (PI)', 'organization': 'Washington University in St. Louis'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo for 14 days.', 'otherNumAtRisk': 20, 'otherNumAffected': 8, 'seriousNumAtRisk': 20, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Azithromycin', 'description': 'Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.', 'otherNumAtRisk': 19, 'otherNumAffected': 7, 'seriousNumAtRisk': 19, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Gastrointestinal adverse events', 'notes': 'Gastrointestinal adverse events (diarrhea, vomiting, or abdominal pain) during the treatment phase were recorded in 7 children treated with azithromycin and in 8 children treated with placebo.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders'}], 'seriousEvents': [{'term': 'Hospitalization for for wheezing episodes', 'notes': '2 participants in the azithromycin group were re-hospitalized for wheezing episodes (3 and 11 months after enrolment) and one patient in the placebo group was hospitalized 3 times for wheezing (all within the first 3 months of the study).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'IL-8 Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for 14 days'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '12,795', 'groupId': 'OG000', 'lowerLimit': '6,265', 'upperLimit': '17,763'}, {'value': '14,676', 'groupId': 'OG001', 'lowerLimit': '7,931', 'upperLimit': '19,270'}]}]}], 'analyses': [{'pValue': '0.6', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 8', 'description': 'Biological outcome: The difference in IL-8 concentrations, measured in serum on day 8 after randomization, among infants treated with azithromycin and those treated with placebo.', 'unitOfMeasure': 'Pg/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Proportion of Participants Who Experience Subsequent Recurrent (≥2) Wheezing Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for 14 days.'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '.50', 'groupId': 'OG000'}, {'value': '.39', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-52 weeks following randomization', 'description': 'Clinical outcome: The difference in the proportion of participants who experience subsequent recurrent (≥2) wheezing episodes among infants treated with azithromycin and those treated with placebo.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Concentrations of IL-8 in Nasal Lavage on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for 14 days.'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2,318', 'groupId': 'OG000', 'lowerLimit': '948', 'upperLimit': '5,476'}, {'value': '865', 'groupId': 'OG001', 'lowerLimit': '357', 'upperLimit': '2,212'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 15', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rates of Drug Related GI Side Effects.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for 14 days.'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One month from randomization', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Likelihood to Develop 3 or More Wheezing Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for 14 days.'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 3-52', 'description': 'Likelihood to develop 3 or more wheezing episodes measured by a Kaplan-Meier survival analysis', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A Kaplan-Meier survival analysis was conducted to compare the likelihood of developing a third episode of wheezing among participants who received azithromycin versus those who received placebo.'}, {'type': 'SECONDARY', 'title': 'Respiratory Symptoms Following RSV Bronchiolitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for 14 days.'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.1', 'spread': '43.1', 'groupId': 'OG000'}, {'value': '36.7', 'spread': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-52 weeks following randomization', 'description': 'Number of days with respiratory symptoms (cough, wheeze, or shortness of breath)', 'unitOfMeasure': 'Number of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Children Who Were Prescribed Inhaled Corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for 14 days.'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-52 weeks following randomization', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With a Physician Diagnosis of Asthma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for 14 days.'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '.25', 'groupId': 'OG000'}, {'value': '.11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 3-52', 'description': 'The proportion of participants with a physician diagnosis of asthma', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo for 14 days.'}, {'id': 'FG001', 'title': 'Azithromycin', 'description': 'Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Azithromycin', 'description': 'Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', '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': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', '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': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-15', 'studyFirstSubmitDate': '2011-11-28', 'resultsFirstSubmitDate': '2016-04-12', 'studyFirstSubmitQcDate': '2011-12-04', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-15', 'studyFirstPostDateStruct': {'date': '2011-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IL-8 Concentrations', 'timeFrame': 'Day 8', 'description': 'Biological outcome: The difference in IL-8 concentrations, measured in serum on day 8 after randomization, among infants treated with azithromycin and those treated with placebo.'}, {'measure': 'Proportion of Participants Who Experience Subsequent Recurrent (≥2) Wheezing Episodes', 'timeFrame': '3-52 weeks following randomization', 'description': 'Clinical outcome: The difference in the proportion of participants who experience subsequent recurrent (≥2) wheezing episodes among infants treated with azithromycin and those treated with placebo.'}], 'secondaryOutcomes': [{'measure': 'Concentrations of IL-8 in Nasal Lavage on Day 15', 'timeFrame': 'Day 15'}, {'measure': 'Rates of Drug Related GI Side Effects.', 'timeFrame': 'One month from randomization'}, {'measure': 'Likelihood to Develop 3 or More Wheezing Episodes', 'timeFrame': 'Week 3-52', 'description': 'Likelihood to develop 3 or more wheezing episodes measured by a Kaplan-Meier survival analysis'}, {'measure': 'Respiratory Symptoms Following RSV Bronchiolitis', 'timeFrame': '3-52 weeks following randomization', 'description': 'Number of days with respiratory symptoms (cough, wheeze, or shortness of breath)'}, {'measure': 'Number of Children Who Were Prescribed Inhaled Corticosteroids', 'timeFrame': '3-52 weeks following randomization'}, {'measure': 'Proportion of Participants With a Physician Diagnosis of Asthma', 'timeFrame': 'Week 3-52', 'description': 'The proportion of participants with a physician diagnosis of asthma'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['RSV Bronchiolitis']}, 'descriptionModule': {'briefSummary': 'This trial is a proof-of-concept pilot study aim to investigate the biologic and clinical effects of early azithromycin treatment in children hospitalized with Respiratory Syncytial Virus (RSV) bronchiolitis.\n\nHYPOTHESES\n\nIn infants hospitalized with RSV bronchiolitis, azithromycin therapy (compared to placebo) will result in:\n\n1. Decreased concentrations of inflammatory mediators (IL-8 as primary outcome) in serum and nasal wash measured on day 8 after randomization.\n2. A smaller proportion of participants with recurrent (≥2) wheezing episodes during weeks 3-52 following randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age: 1-18 months.\n2. Hospitalization for the first episode of RSV bronchiolitis:\n\n * Confirmed RSV infection by positive nasal swab results (viral culture and/or direct antigen detection) from the SLCH virology lab; AND\n * At least two of the following symptoms/signs of bronchiolitis: respiratory rate greater than 40 breaths/minute; cough; wheezing; audible rales, crackles, and/or rhonchi; paradoxical chest movements (retractions).\n3. Duration of respiratory symptoms from initiation of symptoms to admission is 5 days or less. Time of admission will define by the time the child was seen in the ED for the visit that led to hospitalization.\n4. Randomization can be performed within 48 hours from time of admission (defined by time of first set of vital signs obtained on the floor).\n5. Willingness to provide informed consent by the child's parent or guardian\n\n \\-\n\nExclusion Criteria:\n\n1. Prematurity (gestational age \\< 36 weeks).\n2. Presence or history of other significant disease (CNS, lung, cardiac, renal, GI, hepatic disease, hematologic, endocrine or immune disease). Children with atopic dermatitis will not be excluded from the study.\n3. Clinically significant gastroesophageal reflux currently treated with a daily anti-reflux medication (anti- H2 or PPI).\n4. The child has significant developmental delay/failure to thrive, defined as weight \\< 3% for age and gender.\n5. History of previous (before the current episode) wheeze or previous treatment with albuterol.\n6. Treatment (past of present) with corticosteroid (systemic or inhaled) and/or montelukast.\n7. Treatment with any antibiotics in the past 2 weeks.\n8. Treatment with Macrolide antibiotic (Azithromycin, clarithromycin or erythromycin) with the past 4 weeks.\n9. Current treatment with any daily medication (other then albuterol, vitamins or nutritional supplements).\n10. Participation in another clinical trial.\n11. Evidence that the family may be unreliable or nonadherent, or may move from the clinical center area before trial completion.\n12. Contraindication of use of azithromycin or any other macrolide antibiotics."}, 'identificationModule': {'nctId': 'NCT01486758', 'acronym': 'APW-RSV', 'briefTitle': 'Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Pilot Study: Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis', 'orgStudyIdInfo': {'id': '201107151'}, 'secondaryIdInfos': [{'id': 'ICTS, Washington University', 'type': 'OTHER_GRANT', 'domain': 'CTSA402'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Azithromycin', 'description': 'Oral azithromycin', 'interventionNames': ['Drug: Azithromycin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Azithromycin', 'type': 'DRUG', 'description': 'Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.', 'armGroupLabels': ['Azithromycin']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "Department of Pediatrics, Washington University School of Medicine; and St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Avraham Beigelman, MD, MSCI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Avraham Beigelman', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}