Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-13 @ 2:12 PM
Study NCT ID:
NCT03922451
Status:
TERMINATED
Last Update Posted:
2022-03-21
First Post:
2019-04-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077725', 'term': 'Piperacillin, Tazobactam Drug Combination'}, {'id': 'D002437', 'term': 'Cefazolin'}], 'ancestors': [{'id': 'D000078142', 'term': 'Tazobactam'}, {'id': 'D010397', 'term': 'Penicillanic Acid'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010878', 'term': 'Piperacillin'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D013843', 'term': 'Thiazines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'COVID-19 - study and recruitment not feasible', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-07', 'studyFirstSubmitDate': '2019-04-15', 'studyFirstSubmitQcDate': '2019-04-17', 'lastUpdatePostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration: piperacillin-tazobactam', 'timeFrame': 'Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks.', 'description': 'Drug levels will be checked at baseline followed by additional measurements after the dose based on the dosing intervals but anticipated to be 30, 60, 120, 360, 480 minutes after the dose. Dosing regime will be q8-12 hourly pending end organ function (at the discretion of the treating team). The study will be continued for the duration of the Antibiotic therapy whilst on ECMO support and for one set of samples following decannulation.'}, {'measure': 'Plasma concentration: cefazolin', 'timeFrame': 'Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks.', 'description': 'Drug levels will be checked at baseline followed by additional measurements after the dose based on the dosing intervals but anticipated to be 30, 60, 120, 360, 480 minutes after the dose. Dosing regime will be q8-12 hourly pending end organ function (at the discretion of the treating team). The study will be continued for the duration of the Antibiotic therapy whilst on ECMO support and for one set of samples following decannulation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug Effect']}, 'descriptionModule': {'briefSummary': 'This study will measure plasma concentrations of piperacillin-tazobactam and cefazolin in pediatric patients supported with extracorporeal membrane oxygenation (ECMO) aiming to better understand the pharmacokinetics of these medications in this in vivo setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All pediatric patients who are supported on ECMO at Boston Children's Hospital Cardiac Intensive Care Unit (CICU) and receive piperacillin-tazobactam or cefazolin as part of routine care or infection management.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* supported on ECMO\n* receive piperacillin-tazobactam or cefazolin as part of routine care or infection management\n\nExclusion Criteria:\n\n* \\>= 18 years\n* No Consent provided'}, 'identificationModule': {'nctId': 'NCT03922451', 'briefTitle': 'Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support', 'orgStudyIdInfo': {'id': 'IRB-P00030970'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric patients supported on ECMO', 'interventionNames': ['Drug: piperacillin-tazobactam', 'Drug: Cefazolin']}], 'interventions': [{'name': 'piperacillin-tazobactam', 'type': 'DRUG', 'description': 'Administered for infection treatment or prophylaxis per hospital protocol', 'armGroupLabels': ['Pediatric patients supported on ECMO']}, {'name': 'Cefazolin', 'type': 'DRUG', 'description': 'Administered for infection treatment or prophylaxis per hospital protocol', 'armGroupLabels': ['Pediatric patients supported on ECMO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiac Intensivist', 'investigatorFullName': 'Katie Moynihan', 'investigatorAffiliation': "Boston Children's Hospital"}}}}