Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-05 @ 11:18 PM
Study NCT ID:
NCT01778634
Status:
COMPLETED
Last Update Posted:
2020-11-30
First Post:
2013-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016869', 'term': 'Ureaplasma Infections'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}], 'ancestors': [{'id': 'D009180', 'term': 'Mycoplasmatales Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, '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': 'rviscard@som.umaryland.edu', 'phone': '410-706-1913', 'title': 'Rose Marie Viscardi, M.D.', 'organization': 'University of Maryland'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 years 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 51, 'seriousNumAtRisk': 61, 'deathsNumAffected': 6, 'seriousNumAffected': 39}, {'id': 'EG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 51, 'seriousNumAtRisk': 60, 'deathsNumAffected': 5, 'seriousNumAffected': 44}], 'otherEvents': [{'term': 'IV site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric residual >50% volume of feed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Distension', 'notes': 'Abdominal girth increase \\> 2cm from baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loose stools', 'notes': 'stool consistency change with more water content \\<48 h duration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral thrush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukocytosis', 'notes': 'white blood cell count \\>20,000 and \\<40,000 cells/mm3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'notes': 'platelet count \\<100,000 and \\>50,000 cells/mm3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal liver function test', 'notes': 'Serum liver function test (AST/ALT/ or alkaline phosphatase) 1.5-3.5X normal value', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'conjugated hyperbilirubinemia', 'notes': 'Direct bilirubin 1.0-2.0 mg/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 8}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated serum creatinine', 'notes': 'Serum creatinine 1.3-2.3 mg/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'notes': 'hematocrit \\<35% and \\>25%', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'metabolic acidosis', 'notes': 'Serum bicarbonate \\<22 and \\>14 mEq/L', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic alkalosis', 'notes': 'Serum bicarbonate \\>30 and \\<46 mEq/L', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Blood Urea Nitrogen', 'notes': 'Serum BUN \\>27 and \\<60 mg/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'notes': 'Serum potassium \\>5.5 and \\<6.9 mEq/L', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperbilirubinemia', 'notes': 'Total bilirubin \\> 7 and \\<14 mg/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 9}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypernatremia', 'notes': 'Serum sodium \\<132 and \\>120 mEq/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Respiratory Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Apnea', 'notes': 'Breathing pause \\> 20 seconds', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Patent Ductus Arteriosus', 'notes': 'Patent ductus arteriosus confirmed by cardiac echocardiography', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 17}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Necrotizing enterocolitis', 'notes': 'Necrotizing enterocolitis Bell Stage ≥2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ileal stricture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinopathy of prematurity', 'notes': 'Retinopathy of prematurity (ROP) \\>Stage 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'notes': 'hematocrit \\<25', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell count >40,000 cells/mm3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'notes': 'platelet count \\<50,000', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'notes': 'Positive culture from a sterile site (blood or spinal fluid)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood Urea Nitrogen > 60 mg/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercalcemia', 'notes': 'Serum calcium level \\>12.2 mg/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypochloremia', 'notes': 'Serum chloride \\<80 mEq/L', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypernatremia', 'notes': 'Serum sodium \\>155 mEq/L', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalemia', 'notes': 'Serum potassium \\<2.4 mEq/L', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'notes': 'Serum sodium \\<121 mEq/L', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.51', 'ciLowerLimit': '2.53', 'ciUpperLimit': '22.27', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'Bacterial clearance (eradication) will be defined as 3 negative cultures obtained 2 and 5 days post-third dose and 21 d of age. Survival is defined as survival at time of discharge or transfer from the neonatal intensive care unit (NICU).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Survived Until 36 Wks Postmenstrual Age With Physiologic Defined Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post Menstrual Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.11', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.29', 'estimateComment': 'Generalized Estimating Equations with an identity link', 'statisticalMethod': 'Generalized Estimating Equations', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 weeks post menstrual age (one month prior to due date)', 'description': 'Number of Participants who survived until 36 wks postmenstrual age with Physiologic defined bronchopulmonary dysplasia (BPD) based on oxygen-saturation monitoring', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who survived until assessment timepoint 36 weeks post menstrual age (1 month before due date)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death or Neurodevelopmental Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'GEE', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P values are based on GEE to account for twins'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '22-26 months', 'description': 'Neurodevelopmental impairment will be assigned if any of the following are present at 22-26 months adjusted age: moderate to severe cerebral palsy, bilateral blindness, bilateral hearing impairment requiring amplification, Gross Motor Function Classification System score ≥ 2, or Bayley Scale of Infant and Toddler Development, 3rd edition (BSID-III) cognitive or motor score \\<70.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who died prior to the 22-26 months assessment timepoint and participants who were assessed for neurodevelopmental impairments'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pulmonary Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'GEE with multiple imputation', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P values are based on GEE to account for twins. The counts provided refer to to the numbers actually observed. The analysis to determine the p value accounted for the missing 11 patients using multiple imputation.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6-26 months', 'description': 'Parent report of recurrent wheezing and/or chronic cough', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled and randomized in the trial'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '22-26 months', 'description': 'Number of Participants who died from any cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Positive Pressure Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '60'}, {'value': '39', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '56'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "To include non-survivors as bad values of this outcome we imputed a high value for the participants who died. Note, because we analyzed the data using a nonparametric test, the actual value doesn't affect the analysis, only the rank of the value.", 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'Combined number of days receiving mechanical ventilation plus non-invasive modes of positive pressure support.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Oxygen Supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '33', 'upperLimit': '118'}, {'value': '73', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '114.5'}]}]}], 'analyses': [{'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5', 'ciLowerLimit': '-15', 'ciUpperLimit': '26', 'pValueComment': "To include non-survivors as bad values of this outcome we imputed a high value for the participants who died. Note, because we analyzed the data using a nonparametric test, the actual value doesn't affect the analysis, only the rank of the value.", 'estimateComment': 'Bootstrap', 'statisticalMethod': 'Wilcoxon test after multiple outputation', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'Cumulative number of days of receipt of supplemental oxygen', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Air Leaks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'Any pulmonary air leak (pulmonary interstitial emphysema, pneumothorax, pneumomediastinum) confirmed by chest x-ray', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The participants who had air leak at baseline (prior to randomization) were excluded from analysis (3 placebo and 5 azithromycin).'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received Postnatal Steroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.44', 'ciUpperLimit': '2.63', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 weeks', 'description': 'Receipt of steroid medications (hydrocortisone, dexamethasone)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received Non-Study Antibiotics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Generalized Estimating Equations', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'Received Non-study antibiotics following study drug intervention period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK)/Pharmacodynamics (PD) Modelling of Time Course of Azithromycin Plasma Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'number of serum samples concentrations', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study day 1-day 7', 'description': 'Number of serum azithromycin concentrations that fell outside the 90% prediction interval determined by 200 simulated replicates based on the population PK of azithromycin in preterm infants.', 'unitOfMeasure': 'serum conc outside predicted interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of serum samples concentrations', 'denomUnitsSelected': 'number of serum samples concentrations', 'populationDescription': 'No plasma samples from placebo group were analyzed for azithromycin concentrations'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Threshold Retinopathy of Prematurity (ROP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Generalized Estimating Equation', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'Threshold ROP requiring surgical intervention as diagnosed by ophthalmologic examination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants who survived to receive at least 1 eye exam for retinopathy of prematurity'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Necrotizing Enterocolitis (NEC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'Necrotizing enterocolitis ≥ Bell Stage II by radiographic and clinical criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Infections During the NICU Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Generalized Estimating Equations', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'Culture-confirmed bacterial or fungal infection based on culture from sterile site (blood, cerebral spinal fluid, or urine)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Severe Intraventicular Hemorrhage (IVH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.091', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'Number of Participants with Grade III or IV IVH confirmed by cranial ultrasound', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The participants who had a Grade III or IV IVH at baseline (prior to randomization) were excluded (2 placebo and 4 Azithromycin).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Periventricular Leukomalacia (PVL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'The number of Participants with cranial ultrasound confirmed PVL', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Patent Ductus Arteriosus (PDA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Generalized Estimating Equations', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'Detection of PDA by cardiac echocardiogram with left to right shunting, or clinical evidence of murmur, bounding pulses, and widened pulse pressure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who did not have PDA at baseline (prior to randomization). Participants with PDA at baseline were excluded from analysis (5 placebo and 5 azithromycin.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Cardiac Arrhythmia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W'}, {'id': 'OG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 days', 'description': 'Number of Participants with EKG evidence of prolonged QT (QTc \\> 450 ms)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'FG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment period July 1, 2013- August 31, 2016 at 7 U.S. hospital Neonatal Intensive Care Units (NICUs).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo (5% Dextrose)', 'description': 'Placebo\n\nPlacebo: D5W 10 ml/kg every 24 h x 3 days'}, {'id': 'BG001', 'title': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days\n\nAzithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.2', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '26.2', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '26.2', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'gestational age in weeks', 'unitOfMeasure': 'weeks gestation', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '119', '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': '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '43', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', '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': '61', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ureaplasma-positive', 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Any subject who had a respiratory sample (tracheal aspirate and/or nasopharyngeal aspirate) at any time point that was positive for Ureaplasma species confirmed by culture and/or PCR was considered a Ureaplasma-positive subject.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-30', 'size': 2042173, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-02-16T12:08', 'hasProtocol': True}, {'date': '2017-01-30', 'size': 1036729, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-02-16T12:14', 'hasProtocol': False}]}}, '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': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2013-01-22', 'resultsFirstSubmitDate': '2018-03-02', 'studyFirstSubmitQcDate': '2013-01-24', 'lastUpdatePostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-18', 'studyFirstPostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Threshold Retinopathy of Prematurity (ROP)', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'Threshold ROP requiring surgical intervention as diagnosed by ophthalmologic examination'}, {'measure': 'Number of Participants With Necrotizing Enterocolitis (NEC)', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'Necrotizing enterocolitis ≥ Bell Stage II by radiographic and clinical criteria.'}, {'measure': 'Number of Participants With Infections During the NICU Hospitalization', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'Culture-confirmed bacterial or fungal infection based on culture from sterile site (blood, cerebral spinal fluid, or urine)'}, {'measure': 'Number of Participants With Severe Intraventicular Hemorrhage (IVH)', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'Number of Participants with Grade III or IV IVH confirmed by cranial ultrasound'}, {'measure': 'Number of Participants With Periventricular Leukomalacia (PVL)', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'The number of Participants with cranial ultrasound confirmed PVL'}, {'measure': 'Number of Participants With Patent Ductus Arteriosus (PDA)', 'timeFrame': '14 days', 'description': 'Detection of PDA by cardiac echocardiogram with left to right shunting, or clinical evidence of murmur, bounding pulses, and widened pulse pressure.'}, {'measure': 'Number of Participants With Cardiac Arrhythmia', 'timeFrame': '3 days', 'description': 'Number of Participants with EKG evidence of prolonged QT (QTc \\> 450 ms)'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'Bacterial clearance (eradication) will be defined as 3 negative cultures obtained 2 and 5 days post-third dose and 21 d of age. Survival is defined as survival at time of discharge or transfer from the neonatal intensive care unit (NICU).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Survived Until 36 Wks Postmenstrual Age With Physiologic Defined Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post Menstrual Age', 'timeFrame': '36 weeks post menstrual age (one month prior to due date)', 'description': 'Number of Participants who survived until 36 wks postmenstrual age with Physiologic defined bronchopulmonary dysplasia (BPD) based on oxygen-saturation monitoring'}, {'measure': 'Number of Participants With Death or Neurodevelopmental Impairment', 'timeFrame': '22-26 months', 'description': 'Neurodevelopmental impairment will be assigned if any of the following are present at 22-26 months adjusted age: moderate to severe cerebral palsy, bilateral blindness, bilateral hearing impairment requiring amplification, Gross Motor Function Classification System score ≥ 2, or Bayley Scale of Infant and Toddler Development, 3rd edition (BSID-III) cognitive or motor score \\<70.'}, {'measure': 'Number of Participants With Pulmonary Impairment', 'timeFrame': '6-26 months', 'description': 'Parent report of recurrent wheezing and/or chronic cough'}, {'measure': 'Number of Participants Who Died', 'timeFrame': '22-26 months', 'description': 'Number of Participants who died from any cause'}, {'measure': 'Duration of Positive Pressure Support', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'Combined number of days receiving mechanical ventilation plus non-invasive modes of positive pressure support.'}, {'measure': 'Duration of Oxygen Supplementation', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'Cumulative number of days of receipt of supplemental oxygen'}, {'measure': 'Number of Participants Who Experienced Air Leaks', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'Any pulmonary air leak (pulmonary interstitial emphysema, pneumothorax, pneumomediastinum) confirmed by chest x-ray'}, {'measure': 'Number of Participants Who Received Postnatal Steroids', 'timeFrame': '36 weeks', 'description': 'Receipt of steroid medications (hydrocortisone, dexamethasone)'}, {'measure': 'Number of Participants Who Received Non-Study Antibiotics', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'Received Non-study antibiotics following study drug intervention period.'}, {'measure': 'Pharmacokinetics (PK)/Pharmacodynamics (PD) Modelling of Time Course of Azithromycin Plasma Concentrations', 'timeFrame': 'Study day 1-day 7', 'description': 'Number of serum azithromycin concentrations that fell outside the 90% prediction interval determined by 200 simulated replicates based on the population PK of azithromycin in preterm infants.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ureaplasma parvum', 'Ureaplasma urealyticum', 'prematurity', 'bronchopulmonary dysplasia', 'azithromycin'], 'conditions': ['Ureaplasma Infections']}, 'referencesModule': {'references': [{'pmid': '21098694', 'type': 'BACKGROUND', 'citation': 'Hassan HE, Othman AA, Eddington ND, Duffy L, Xiao L, Waites KB, Kaufman DA, Fairchild KD, Terrin ML, Viscardi RM. Pharmacokinetics, safety, and biologic effects of azithromycin in extremely preterm infants at risk for ureaplasma colonization and bronchopulmonary dysplasia. J Clin Pharmacol. 2011 Sep;51(9):1264-75. doi: 10.1177/0091270010382021. Epub 2010 Nov 23.'}, {'pmid': '32170033', 'type': 'DERIVED', 'citation': 'Viscardi RM, Terrin ML, Magder LS, Davis NL, Dulkerian SJ, Waites KB, Ambalavanan N, Kaufman DA, Donohue P, Tuttle DJ, Weitkamp JH, Hassan HE, Eddington ND. Randomised trial of azithromycin to eradicate Ureaplasma in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2020 Nov;105(6):615-622. doi: 10.1136/archdischild-2019-318122. Epub 2020 Mar 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether intravenous azithromycin is effective in eradicating Ureaplasma respiratory tract infection in preterm infants born at 24 to 28 weeks gestation.', 'detailedDescription': 'The study design will be a double-blind, placebo-controlled clinical trial to test the efficacy and safety of azithromycin 20 mg/kg x 3 days to eradicate Ureaplasma spp from the respiratory tract of preterm infants 24 weeks 0 days to 28 weeks 6 days gestation exposed to positive pressure ventilation. The primary outcome will be survival with microbiological eradication of Ureaplasma defined as survival to discharge or transfer with 3 negative cultures obtained post-therapy. Secondary outcomes will include physiologic BPD at 36 weeks post-menstrual age (PMA), overall mortality, incidence of co-morbidities of prematurity such as intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, bacterial and fungal nosocomial infection, pulmonary air leak, patent ductus arteriosus, retinopathy of prematurity, number of days of positive pressure ventilation, number of days of oxygen supplementation, use of postnatal steroids, and use of non-study antibiotics. At 6 and 18 months adjusted age, a pulmonary outcome questionnaire will be administered by phone or in person interview. At 18-22 months adjusted age, neurodevelopmental outcomes will be assessed by 1) Bayley Scale of Infant and Toddler Development, 3rd edition (BSID-III); 2) Amiel-Tison neurologic examination; 3) Gross Motor Function Classification System; and 4) medical record review for hearing impairment with or without amplification and vision impairment (vision \\<20/200).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '72 Hours', 'minimumAge': '2 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age 24 weeks 0 days-28weeks 6 days by best obstetrical estimate\n* \\<72 h age\n* Positive pressure ventilation for at least 1 hour duration during the first 72 hours of life\n* Presence of indwelling intravenous line for drug administration\n\nExclusion Criteria:\n\n* Any patient judged to be non-viable or for whom withdrawal of life support is planned\n* Patients with major lethal congenital anomalies\n* Triplets or higher order multiples\n* Patients delivered for maternal indications (low risk of Ureaplasma colonization)\n* Patients with EKG QT interval corrected for heart rate (Qtc) ≥ 450 ms\n* Patients with significant hepatic impairment (direct bilirubin \\>1.5 mg/dL)\n* Patients exposed to other systemic macrolide\n* Patients with clinically suspected Ureaplasma central nervous system (CNS) infection or other confirmed bacterial/viral infection\n* Patients participating in other clinical trials involving investigational products.'}, 'identificationModule': {'nctId': 'NCT01778634', 'acronym': 'AZIPIII', 'briefTitle': 'Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'A Phase IIb Randomized, Placebo-controlled, Double-blind Trial of Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants', 'orgStudyIdInfo': {'id': 'HP-00054998'}, 'secondaryIdInfos': [{'id': 'R01HD067126', 'link': 'https://reporter.nih.gov/quickSearch/R01HD067126', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (5% dextrose)', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Azithromycin', 'description': 'Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days', 'interventionNames': ['Drug: Azithromycin']}], 'interventions': [{'name': 'Azithromycin', 'type': 'DRUG', 'otherNames': ['Zithromax'], 'description': 'Azithromycin intravenous 20 mg/kg every 24 h x 3 days', 'armGroupLabels': ['Azithromycin']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['equal volume of 5% dextrose water'], 'description': 'D5W', 'armGroupLabels': ['Placebo (5% dextrose)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249-7335', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health Services', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21202', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mercy Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '37232-9544', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': "Monroe Carell Jr. Children's Hospital at Vanderbilt", 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '22908-0386', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Rose M Viscardi, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Maryland, College Park'}, {'name': 'Pamela Donohue, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}, {'name': 'Namasivayam Ambalavanan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'David A Kaufman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}, {'name': 'Michael L Terrin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, College Park'}, {'name': 'Susan J Dulkerian, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mercy Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'Mercy Medical Center', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'University of Virginia', 'class': 'OTHER'}, {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': 'Christiana Care Health Services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Rose Viscardi', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}