Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-02-23 @ 6:24 AM
Study NCT ID:
NCT02388035
Status:
COMPLETED
Last Update Posted:
2015-06-04
First Post:
2015-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002439', 'term': 'Cefotaxime'}], 'ancestors': [{'id': 'D002505', 'term': 'Cephacetrile'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 254}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-03', 'studyFirstSubmitDate': '2015-03-09', 'studyFirstSubmitQcDate': '2015-03-12', 'lastUpdatePostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Organisms detected with their antibiotics sensitivity', 'timeFrame': '8 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['profiles changes', 'microorganisms', 'cefotaxime', 'SBP', 'Egyptian', 'effective antibiotics'], 'conditions': ['Spontaneous Bacterial Peritonitis']}, 'descriptionModule': {'briefSummary': 'Spontaneous bacterial peritonitis (SBP) is a serious complication in cirrhotic patients, and the changes in the microbiological characteristics reported in the last years are impacting the choice of antibiotic used in the treatment. Cefotaxime has been the most extensively studied antibiotic for this infection. It is considered to be one of the first choice antibiotics because of low toxicity and excellent efficacy. Treatment of SBP by intravenous cefotaxime should be administered for a minimum 5 days. Antibiotic-resistant microorganisms have been increasingly reported especially to cefotaxime and its effect on the clinical outcome in treating SBP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with liver cirrhosis and ascites and clinical findings suspicious of ascitic fluid infection\n\nExclusion Criteria:\n\n* Patients were excluded if they received antibiotics ten days prior to the hospital admission or there is evidence of secondary bacterial peritonitis, tuberculous peritonitis, malignant ascites or ascites due to other causes e.g. cardiac or renal diseases'}, 'identificationModule': {'nctId': 'NCT02388035', 'briefTitle': 'Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Nasser Institute For Research and Treatment'}, 'officialTitle': 'Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis', 'orgStudyIdInfo': {'id': 'HHAEREDS-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SBP-group 1', 'description': 'Spontanous bacterial peritonitis', 'interventionNames': ['Drug: Cefotaxime']}, {'type': 'EXPERIMENTAL', 'label': 'CNNA-group 2', 'description': 'Culture negative neutrocytic ascites', 'interventionNames': ['Drug: Cefotaxime']}, {'type': 'EXPERIMENTAL', 'label': 'MNBA-group 3', 'description': 'monomicrobial non-neutrocytic ascites', 'interventionNames': ['Drug: Cefotaxime']}, {'type': 'NO_INTERVENTION', 'label': 'group 4', 'description': 'no evidence of ascitic fluid infection'}], 'interventions': [{'name': 'Cefotaxime', 'type': 'DRUG', 'armGroupLabels': ['CNNA-group 2', 'MNBA-group 3', 'SBP-group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Shubra', 'country': 'Egypt', 'facility': 'Nasser institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Ahmed Ali Elbaz', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Dr Ahmed Ali Elbaz', 'investigatorAffiliation': 'Nasser Institute For Research and Treatment'}}}}