Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT03502356
Status:
UNKNOWN
Last Update Posted:
2018-04-18
First Post:
2018-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Addition of Azithromycin to Cefazolin Will Reduce Post CS Infections More Than Cefazolin Only.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D002437', 'term': 'Cefazolin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Control Group:\n\nThis group will include 200women undergoing elective cs. In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative.\n\nStudy Group:\n\nThis group will include 200women undergoing elective cs. In this group, patients will receive only standard prophylaxis antibiotic(CEFAZOLIN)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-11', 'studyFirstSubmitDate': '2018-04-11', 'studyFirstSubmitQcDate': '2018-04-11', 'lastUpdatePostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endometritis', 'timeFrame': '6 weeks after surgery', 'description': 'Endometritis was defined as the presence of at least two of the following signs with no other recognized cause: fever (temperature of at least 38°C \\[100.4°F\\]), abdominal pain, uterine tenderness, or purulent drainage from the uterus'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Randomized Controll Trial']}, 'descriptionModule': {'briefSummary': 'The good standard antibiotic prophylaxis pre elective C S is cefazolin and this study will approve addition of azithromycin to cefazolin will reduce post CS infections more than cefazolin only.', 'detailedDescription': 'Patiants and methods\n\nRandomization:\n\nPatients fulfilling the inclusion criteria will be randomized to two groups. Both two group will receive standard prophylaxis antibiotic CEFAZOLIN (zinol) (at a dose of 1 g) 2 hours preoperative.\n\nControl Group:\n\nThis group will include 200women undergoing elective cs. In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative.\n\nStudy Group:\n\nThis group will include 200women undergoing elective cs. In this group, patients will receive only standard prophylaxis antibiotic(CEFAZOLIN)\n\nInclusion criteria:\n\n* Gestational age of 37 0/7 weeks and greater\n* Elective cesarean section\n* Medicaly free pregnant women\n\nExclusion criteria:\n\n* a known allergy to azithromycin\n* obstetric complications\n* azithromycin use within 7 days before randomization\n* chorioamnionitis or other infection requiring postpartum antibiotic therapy\n* Pre-gestational diabetes'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age of 37 0/7 weeks and greater\n* Elective cesarean section\n* Medicaly free pregnant women\n\nExclusion Criteria:\n\n* a known allergy to azithromycin\n* obstetric complications\n* azithromycin use within 7 days before randomization\n* chorioamnionitis or other infection requiring postpartum antibiotic therapy\n* Pre-gestational diabetes'}, 'identificationModule': {'nctId': 'NCT03502356', 'briefTitle': 'Addition of Azithromycin to Cefazolin Will Reduce Post CS Infections More Than Cefazolin Only.', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'ADDATION OF Azithromycin TO CEFAZOLIN PRE ELECTIVE C S', 'orgStudyIdInfo': {'id': '2377'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'This group will include 200women undergoing elective cs. In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative.', 'interventionNames': ['Drug: Azithromycin']}, {'type': 'NO_INTERVENTION', 'label': 'Study Group', 'description': 'This group will include 200women undergoing elective cs. In this group, patients will receive only standard prophylaxis antibiotic(CEFAZOLIN)'}], 'interventions': [{'name': 'Azithromycin', 'type': 'DRUG', 'otherNames': ['Cefazolin'], 'description': 'In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23', 'city': 'Cairo', 'state': 'Elabasy', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'mohamed 20 amar, md', 'role': 'CONTACT', 'email': 'drmohamed145@gmil.com', 'phone': '01024706467', 'phoneExt': '02'}], 'facility': 'Ain Shams', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'mohamed 20 amar, md', 'role': 'CONTACT', 'email': 'drmohamed145@gmil.com', 'phone': '01024706467', 'phoneExt': '02'}], 'overallOfficials': [{'name': 'mohamed 20 amar, md', 'role': 'STUDY_CHAIR', 'affiliation': 'ain shams'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'cario egypt', 'investigatorFullName': 'mohamed abd elhamied abd elgaber', 'investigatorAffiliation': 'Ain Shams University'}}}}