Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-01-05 @ 6:27 PM
Study NCT ID:
NCT04294069
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2020-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563032', 'term': 'Preterm Premature Rupture of the Membranes'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-24', 'studyFirstSubmitDate': '2020-02-18', 'studyFirstSubmitQcDate': '2020-03-02', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Azithromycin trough in amniotic fluid', 'timeFrame': '8 days', 'description': 'Primary outcome is the mean difference in azithromycin trough (Cmin) in amniotic fluid between the two dosing regimens using nonparametric test'}], 'secondaryOutcomes': [{'measure': 'IL-6 in amniotic fluid', 'timeFrame': '8 days', 'description': 'Mean difference in IL-6 at delivery or 8 days (which ever is first)'}, {'measure': 'IL-8 in cord blood', 'timeFrame': '3 months (delivery)', 'description': 'Mean difference in IL-8 in cord blood'}, {'measure': 'Respiratory ureaplasma colonization in neonate', 'timeFrame': '3 months', 'description': 'Culture of nasopharyngeal swab within 48 hours of delivery in neonates'}, {'measure': 'Latency to delivery', 'timeFrame': '3 months', 'description': 'Number days from admission to delivey'}, {'measure': 'Intra-amniotic infection', 'timeFrame': '3 months (delivery)', 'description': 'Incidence of maternal intra-amniotic infection at delivery'}, {'measure': 'Trend in amniotic fluid cytokines', 'timeFrame': '8 days', 'description': 'TNF alpha, IL-1B, IL-6, IL-8 over 8 day period from admission'}, {'measure': 'ureaplasma colonization of membranes', 'timeFrame': '3 months', 'description': 'Culture swab taken of membranes after delivery'}, {'measure': 'Histologic chorioamnionitis', 'timeFrame': '3 months (delivery)', 'description': 'incidence of histologic chorioamnionitis in placental pathology'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Premature Rupture of Membrane']}, 'descriptionModule': {'briefSummary': 'This is a pilot randomized controlled trial to assess the pharmacokinetics and pharmacodynamics of azithromycin in pregnant singletons admitted with preterm premature rupture of membranes (PPROM) at 24 0/7- 33 0/7. Participants will be randomized 1:1 to either 1000mg azithromycin orally once or 500mg azithromycin orally daily for seven days in addition to standard care.', 'detailedDescription': 'This is a pilot randomized controlled trial to assess the pharmacokinetics and pharmacodynamics of azithromycin in pregnant singletons admitted with preterm premature rupture of membranes (PPROM) at 24 0/7- 33 0/7. Participants will be randomized 1:1 to either 1000mg azithromycin orally once or 500mg azithromycin orally daily for seven days in addition to standard care. During the course of eight days participants will have serial collection of amniotic fluid, maternal serum; and at delivery, of placenta, membrane, and cord blood. After delivery, neonatal respiratory samples will be collected as well.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Singleton gestation 24 0/7 -33 0/7 weeks'\n* Diagnosed with preterm premature rupture of membranes:\n\n * History consistent with ruptured membranes (ie leaking, gush of fluid)\n * Sterile speculum exam with pooling\n * Fluid positive for ferning and/or nitrazine\n * With or without confirmatory test such as Amnisure\n\nExclusion Criteria:\n\n* • Contraindication to azithromycin\n\n * Active labor, abruption, chorioamnionitis at enrollment\n * Other contraindication to expectant management of PPROM at enrollment"}, 'identificationModule': {'nctId': 'NCT04294069', 'acronym': 'ADAPT', 'briefTitle': 'Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Azithromycin Pharmacokinetics and Pharmacodynamics in Pregnancy and Preterm Birth Prevention: Optimizing Dosing to Improve Maternal and Neonatal Outcomes', 'orgStudyIdInfo': {'id': '20G.119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Azithromycin 500mg', 'description': '500mg azithromycin PO daily for seven days', 'interventionNames': ['Drug: Azithromycin 500 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Azithromycin 1000mg', 'description': '1000mg azithromycin PO once at admission', 'interventionNames': ['Drug: Azithromycin Oral Product']}], 'interventions': [{'name': 'Azithromycin 500 mg', 'type': 'DRUG', 'description': '500mg azithromycin PO for seven days starting on admission', 'armGroupLabels': ['Azithromycin 500mg']}, {'name': 'Azithromycin Oral Product', 'type': 'DRUG', 'description': '1000mg azithromycin PO once at admission', 'armGroupLabels': ['Azithromycin 1000mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Rupsa C Boelig, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': '1 year after publication of results', 'ipdSharing': 'YES', 'description': 'IPD available on request pending completion of data sharing agreement and approval of information requested', 'accessCriteria': 'IPD available on request pending completion of data sharing agreement and approval of information requested'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Christiana Care Health Services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}