Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-30 @ 2:56 AM
Study NCT ID:
NCT01714557
Status:
UNKNOWN
Last Update Posted:
2012-10-26
First Post:
2012-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009503', 'term': 'Neutropenia'}], 'ancestors': [{'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010878', 'term': 'Piperacillin'}, {'id': 'D000077725', 'term': 'Piperacillin, Tazobactam Drug Combination'}], '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'}, {'id': 'D000078142', 'term': 'Tazobactam'}, {'id': 'D010397', 'term': 'Penicillanic Acid'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-25', 'studyFirstSubmitDate': '2012-07-04', 'studyFirstSubmitQcDate': '2012-10-25', 'lastUpdatePostDateStruct': {'date': '2012-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'febrile rate', 'timeFrame': '3 weeks after beginning of prophylaxis', 'description': 'In both group, how many patients developed febrile.'}], 'secondaryOutcomes': [{'measure': 'Microbiologic efficacy in febrile patients', 'timeFrame': '3 weeks after beginning of prophylaxis', 'description': 'The success rate and failure rate will be calculated.\n\n1. The microbiologic culture is positive at 3 weeks of prophylaxis, showing pathogen sensitive to Piperacillin/tazobactam, the case will be evaluated as breakthrough infection, that means microbiologic failure.\n2. The microbiologic culture is negative at 3 weeks of prophylaxis,, or positive fungus or non-typical organisms, the case will be evaluated as microbiologic success.'}, {'measure': 'Recovery rate from neutropenia', 'timeFrame': '3 weeks after beginning of prophylaxis', 'description': 'How many patients reached the ANC \\> 0.5×109/L more than 3 days.'}, {'measure': 'AE', 'timeFrame': '3 weeks after beginning of prophylaxis', 'description': 'How many patients developed unexpected medical events.'}, {'measure': 'Cost of drug and hospital-stay', 'timeFrame': '3 weeks after beginning of prophylaxis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neutropenia', 'Hematopoietic Stem Cell Transplantation']}, 'descriptionModule': {'briefSummary': 'Neutropenia is very common in patients received hematopoietic stem cell transplantation, with median duration of about 14 days. Almost all neutropenia will suffer from febrile without prophylactic antibiotics. IDSA recommended fluoroquinolones as prophylaxis in neutropenia patients of high risks, while in China, major pathogens possess high resistance to fluoroquinolones. It is not clear whether prophylaxis is of benefit, nor the appropriate prophylaxis regimen.\n\nThe current study will evaluate the three different regimen:\n\n1. No prophylaxic antibiotic\n2. Piperacillin as prophylaxis for neutropenia patients. Piperacillin has anti-pseudomonas activity.\n3. Piperacillin/tazobactam as prophylaxis for neutropenia patients. Piperacillin/tazobactam has highest susceptibility rate among common anti-pseudomonas antibiotics.', 'detailedDescription': '1. Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation.\n2. Randomize the neutropenia patients into 3 groups.\n3. Receive 3 regimen.\n4. Full record of clinical data, including background diseases, previous antibiotics within 90 days, febrile or not at the TOC.\n5. For patients developed febrile, imipenem will be prescribed, even if the patient received no prophylaxis. At the same time, the follow-up ended.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 13-65 years\n* Received Autologous or Allogeneic hematopoietic stem cell transplantation.\n* ECOG score 0-1.\n* ICF is available.\n\nExclusion Criteria:\n\n* Allergic to any therapy drug.\n* Documented infection before neutropenia.\n* Renal dysfunction.\n* Suffering from central nervous system or mental disease.'}, 'identificationModule': {'nctId': 'NCT01714557', 'briefTitle': 'Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Piperacillin/Tazobactam for Prophylaxis in Patients of Neutropenia After Hematopoietic Stem Cell Transplantation - A Pilot Study', 'orgStudyIdInfo': {'id': 'TZP-HEM-20120608'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No prophylaxis'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'piperacillin', 'interventionNames': ['Drug: Piperacillin']}, {'type': 'EXPERIMENTAL', 'label': 'piperacillin/tazobactam', 'interventionNames': ['Drug: Piperacillin-tazobactam combination product']}], 'interventions': [{'name': 'Piperacillin', 'type': 'DRUG', 'description': '4.0g q8h 3-5 days', 'armGroupLabels': ['piperacillin']}, {'name': 'Piperacillin-tazobactam combination product', 'type': 'DRUG', 'otherNames': ['Tazocin'], 'description': '4.5g q8h 3-5 days', 'armGroupLabels': ['piperacillin/tazobactam']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Wenrong Huang, Doctor', 'role': 'CONTACT', 'email': 'huangwr301@yahoo.com.cn'}], 'facility': 'Chinese PLA general hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'wenrong huang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Employee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate director, Hematology, Chinese PLA General hospital', 'investigatorFullName': 'Wenrong Huang', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}