Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-09 @ 8:12 AM
Study NCT ID:
NCT01503606
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2011-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane
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': 'D002437', 'term': 'Cefazolin'}, {'id': 'D017291', 'term': 'Clarithromycin'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-18', 'studyFirstSubmitDate': '2011-12-25', 'studyFirstSubmitQcDate': '2012-01-01', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neonatal composite morbidity', 'timeFrame': 'Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks', 'description': '1. respiratory distress syndrome(RDS)\n2. bronchopulmonary dysplasia(BPD)\n3. intraventricular hemorrhage(IVH,≥grade 3)\n4. retinopathy of prematurity(ROP,≥grade 3)\n5. necrotizing enterocolitis(NEC,≥stage 2)\n6. proven neonatal sepsis'}], 'secondaryOutcomes': [{'measure': 'infantile neurologic outcome', 'timeFrame': 'at 6 months and 1 year of corrected age', 'description': 'The outcome will be evaluated in five sub-domains (development, neurologic examination, Bayley Scales of Infant Development-II, vision, and hearing). The final outcome scale was divided into normal, mild, moderate, and severe disability'}]}, 'conditionsModule': {'keywords': ['preterm premature rupture of membrane', 'antibiotics', 'duration', 'cefazolin', 'clarithromycin'], 'conditions': ['Preterm Premature Rupture of Membrane']}, 'referencesModule': {'references': [{'pmid': '36746334', 'type': 'DERIVED', 'citation': 'Sung JH, Kim JH, Kim Y, Choi YS, Hong S, Choi SJ, Kim JS, Roh CR, Oh SY. A randomized clinical trial of antibiotic treatment duration in preterm pre-labor rupture of membranes: 7 days vs until delivery. Am J Obstet Gynecol MFM. 2023 Apr;5(4):100886. doi: 10.1016/j.ajogmf.2023.100886. Epub 2023 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the neonatal outcome and infant neurologic outcome whose mother were treated with cefazolin plus clarithromycin for one week or until delivery after preterm premature rupture of membrane.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preterm premature rupture of membrane(PPROM), PA 22+0\\~34+0wks\n* ROM \\<72 hrs before randomization\n* cervical dilatation \\<3cm\n* uterine contraction less than 4 times per 1 hr\n\nExclusion Criteria:\n\n* Major fetal malformation\n* Rupture of the membrane \\>72hrs before randomization\n* Vaginal bleeding\n* IIOC (incompetent internal os of cervix)\n* Placenta previa\n* Gestational diabetes or overt diabetes\n* Hypertensive disorders in pregnancy\n* Liver cirrhosis\n* Acute renal failure'}, 'identificationModule': {'nctId': 'NCT01503606', 'briefTitle': 'Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane, Phase III Study.', 'orgStudyIdInfo': {'id': '2011-07-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'one-week treatment group', 'description': 'Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization for one week', 'interventionNames': ['Drug: Cefazolin', 'Drug: Clarithromycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'until-delivery treatment group', 'description': 'Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization until delivery', 'interventionNames': ['Drug: Cefazolin', 'Drug: Clarithromycin']}], 'interventions': [{'name': 'Cefazolin', 'type': 'DRUG', 'description': 'Cefazolin 1.0gm IVs q 12 hours after randomization for one week', 'armGroupLabels': ['one-week treatment group']}, {'name': 'Clarithromycin', 'type': 'DRUG', 'description': 'clarithromycin 500mg po bid after randomization for one week', 'armGroupLabels': ['one-week treatment group']}, {'name': 'Cefazolin', 'type': 'DRUG', 'description': 'Cefazolin 1.0gm IVs q 12 hours after randomization until delivery', 'armGroupLabels': ['until-delivery treatment group']}, {'name': 'Clarithromycin', 'type': 'DRUG', 'description': 'clarithromycin 500mg po bid after randomization until delivery', 'armGroupLabels': ['until-delivery treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical center, Sungkyunkwan University School of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Soo-young Oh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Oh Soo Young', 'investigatorAffiliation': 'Samsung Medical Center'}}}}