Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-30 @ 8:09 PM
Study NCT ID:
NCT04895657
Status:
COMPLETED
Last Update Posted:
2021-05-20
First Post:
2021-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extended-infusion of Piperacillin-Tazobactam Versus Intermittent Infusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010878', 'term': 'Piperacillin'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-24', 'size': 316833, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-05T17:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-18', 'studyFirstSubmitDate': '2021-04-19', 'studyFirstSubmitQcDate': '2021-05-18', 'lastUpdatePostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical cure', 'timeFrame': 'ICU length of stay, assessed up to 30 days', 'description': 'Clinical cure, expressed in percentage, will be considered fulfilled if all the following criteria are met : Cure or improvement of clinical signs and symptoms caused by the infection, normalized WBCs and body temperature.'}, {'measure': 'Total cost', 'timeFrame': 'ICU length of stay, assessed up to 30 days', 'description': 'Cost in Dollars (prices of drugs ,supplies prices, preparation, administration, daily hospital stay cost )'}], 'secondaryOutcomes': [{'measure': 'ICU Length of stay', 'timeFrame': 'ICU length of stay, assessed up to 30 days', 'description': 'ICU Length of stay in Days'}, {'measure': 'Mortality', 'timeFrame': 'ICU length of stay, assessed up to 30 days', 'description': 'percentage'}, {'measure': 'Readmission within 30- days', 'timeFrame': '30 days', 'description': 'Days'}, {'measure': 'Adverse drug events', 'timeFrame': 'ICU length of stay, assessed up to 30 days', 'description': 'Any adverse event occurring during study drug administration'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antibiotics', 'Beta-lactams', 'Continuous administration'], 'conditions': ['Gram-Negative Infections']}, 'descriptionModule': {'briefSummary': 'Continuous-infusion of piperacillin/tazobactam over 4 hrs instead of 30-minute intermittent dosage regimen has shown observable outcomes. Our objective is to assess whether continuous infusion of piperacillin/tazobactam is superior in terms of efficacy, safety and cost to the intermittent regimen to treat suspected or proved infections due to gram negative bacteria. The setting is Critical Care Medicine Department at Cairo University Hospitals. Methods A prospective randomized comparative study.', 'detailedDescription': "A total of 56 patients were recruited from ICU- Cairo University Hospitals. All adult critically ill patients admitted to Critical Care Medicine Department with suspected or confirmed bacterial infections on admission or during their ICU stay were assessed for inclusion into the study. All patients were subjected to the following: A. Patient's full history: Age, sex ,medical history ,concurrent diseases, concurrent medications\n\nB. Patient evaluation and assessment:\n\nThe following were evaluated at baseline and periodically thereafter until day of stopping antibiotic, discharge and/or death :\n\n1. Kidney functions (Serum creatinine, blood urea nitrogen)\n2. Liver functions (ALT, AST, Bil D, Bil T, Albumin)\n3. Complete blood count\n4. Microbiological Evaluation: Cultures and sensitivity tests from suspected site of infection\n5. Clinical signs and symptoms of infection documented by the attending physician on patient's medical record\n6. APACHE II Variables"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-74 years\n* Expected ICU stay more than 24 hours\n\nExclusion Criteria:\n\n* Allergy or potential allergy to the study medications\n\n * Pregnancy\n * Patients with CrCl\\< 20 ml/min or on dialysis\n * Cancer patients'}, 'identificationModule': {'nctId': 'NCT04895657', 'briefTitle': 'Extended-infusion of Piperacillin-Tazobactam Versus Intermittent Infusion', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Extended-infusion Piperacillin-Tazobactam Versus Intermittent-Infusion Dosing Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Infections.', 'orgStudyIdInfo': {'id': '198'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Piperacillin/Tazobactam Intermittent infusion', 'description': '4.5 gm Piperacillin/Tazobactam I.V intermittent over 30 min. every 8 hours.', 'interventionNames': ['Drug: Piperacillin/Tazobactam Intermittent infusion']}, {'type': 'OTHER', 'label': 'Piperacillin/Tazobactam Continuous infusion', 'description': '4.5 gm Piperacillin/Tazobactam I.V extended infusion over 4 hours every 8 hours.', 'interventionNames': ['Drug: Piperacillin/Tazobactam Continuous infusion']}], 'interventions': [{'name': 'Piperacillin/Tazobactam Continuous infusion', 'type': 'DRUG', 'otherNames': ['Piprataz injection'], 'description': 'Continuous infusion', 'armGroupLabels': ['Piperacillin/Tazobactam Continuous infusion']}, {'name': 'Piperacillin/Tazobactam Intermittent infusion', 'type': 'DRUG', 'otherNames': ['Piprataz injection'], 'description': 'Intermittent infusion', 'armGroupLabels': ['Piperacillin/Tazobactam Intermittent infusion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching assistant', 'investigatorFullName': 'Christina Medhat', 'investigatorAffiliation': 'Ain Shams University'}}}}