Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-31 @ 11:33 AM
Study NCT ID:
NCT06690905
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2024-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Achievement of a Pharmacodynamic Target of Piperacillin-Tazobactam for the Population With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2024-11-12', 'studyFirstSubmitQcDate': '2024-11-13', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of adherence to the sampling protocol', 'timeFrame': 'At 24 hours of treatment of piperacillin-tazobactam after randomization', 'description': 'Rate of patients whose blood collection takes place 24 hours after the start of administration of piperacillin-tazobactam according to the method of administration assigned during randomization'}, {'measure': 'Recruitment rate', 'timeFrame': 'At the randomization', 'description': 'Proportion of patients meeting the eligibility criteria who consent to the study.'}, {'measure': 'Achievement of a prespecified number of patients recruited per month', 'timeFrame': 'At the randomization', 'description': 'Achievement of a number of patients recruited per month of 5 to 8 patients'}, {'measure': 'Proportion of eligible patients relative to the total population who received a piperacillin-tazobactam for the study period', 'timeFrame': 'From the screening period to the enrollment, assessed up to 24 hours after the start of a piperacillin-tazobactam prescription', 'description': 'Proportion of eligible patients relative to the total population who received a piperacilline-tazobactam for the study period'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients reaching the target of fT>MIC equal to 100% after 24 hours of piperacillin-tazobactam according to the assigned intervention', 'timeFrame': 'At 24 hours of treatment of piperacillin-tazobactam after randomization', 'description': 'Proportion of patients reaching the target of the time the free concentration of the drug remains above the MIC during the dosing interval (i.e. fT\\>MIC) equal to 100% after 24 hours of piperacillin-tazobactam according to the assigned intervention'}, {'measure': 'Number of days of piperacillin-tazobactam treatment under study', 'timeFrame': 'From enrollment to the last dose of the intervention, assessed up to 42 days', 'description': 'Evaluate the number of days of piperacillin-tazobactam treatment under study'}, {'measure': 'Need of escalation to carbapenems antibiotics', 'timeFrame': 'From enrollment to the last dose of the intervention, assessed up to 42 days', 'description': 'Assess if there has been an escalation to carbapenem antibiotics'}, {'measure': 'Incidence of adverse events attributed to the intervention', 'timeFrame': 'From enrollment to the last dose of the intervention, assessed up to 42 days', 'description': 'Evaluate the incidence of adverse effects attributed to the intervention'}, {'measure': 'Number of days until de-escalation to a narrower spectrum injectable antibiotic or to an oral switch', 'timeFrame': 'From enrollment to the last dose of the intervention, assessed up to 42 days', 'description': 'Evaluate the number of days until de-escalation to a narrower spectrum injectable antibiotic or to an oral switch, if necessary'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Piperacillin-tazobactam', 'Pharmacodynamics'], 'conditions': ['Infections', 'Obesity and Obesity-related Medical Conditions']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the feasibility of an open randomized controlled study which would assess the proportion patients with obesity who will have a favorable pharmacodynamic parameter (i.e. fT\\> 100% MIC) after 24 hours of piperacillin-tazobactam administered as a prolonged intermittent infusion compared to a standard infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18 years and older)\n* Patients hospitalized at Hôpital Charles-Le Moyne\n* Obesity (as defined by a body mass index of ≥ 30 kg/m\\^2)\n* Piperacillin-tazobactam prescription initiated within last 24 hours\n* Planned duration of piperacillin-tazobactam of 24 hours or more\n\nExclusion Criteria:\n\n* Documented allergy to beta-lactams of the penicillin class\n* Patients with renal replacement therapy (hemodialysis, peritoneal dialysis, continuous venovenous hemodiafiltration)\n* Pregnancy\n* History of seizures or epilepsy, active seizures or epilepsy treated with antiepileptic drug therapy\n* Patients on prolonged intermittent infusion or continuous infusion of piperacillin-tazobactam before randomization'}, 'identificationModule': {'nctId': 'NCT06690905', 'briefTitle': 'Evaluation of the Achievement of a Pharmacodynamic Target of Piperacillin-Tazobactam for the Population With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'CR-CSSS Champlain-Charles-Le Moyne'}, 'officialTitle': 'Evaluation of the Achievement of a Pharmacodynamic Target of Piperacillin-Tazobactam for the Population With Obesity: an Open Randomized Controlled Feasibility Study', 'orgStudyIdInfo': {'id': '2025-956'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Piperacillin-tazobactam administered in a prolonged infusion', 'description': 'Piperacillin-tazobactam dose will be administered over 3 hours for piperacillin-tazobactam dosages every 6 hours or over 4 hours for piperacillin-tazobactam dosages every 8 hours.', 'interventionNames': ['Drug: Piperacillin-tazobactam administered in a prolonged infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Piperacillin-tazobactam administered in a standard infusion', 'description': "Piperacillin-tazobactam dose will be administered over 30 minutes for every piperacilline-tazobactam administered in the study (as instructed by the drug's monograph)", 'interventionNames': ['Drug: Piperacillin-tazobactam administered in a standard infusion']}], 'interventions': [{'name': 'Piperacillin-tazobactam administered in a prolonged infusion', 'type': 'DRUG', 'description': 'For patients with the prolonged infusion intervention, the piperacillin-tazobactam dose will be administered via 100 ml 0.9% NaCl mini-bags infused and a volumetric pump over 3 hours for piperacillin-tazobactam dosages every 6 hours or overs 4 hours for piperacillin-tazobactam dosages every 8 hours.', 'armGroupLabels': ['Piperacillin-tazobactam administered in a prolonged infusion']}, {'name': 'Piperacillin-tazobactam administered in a standard infusion', 'type': 'DRUG', 'description': "For patients with the standard infusion intervention, the piperacillin-tazobactam dose will be administered over 30 minutes for every piperacilline-tazobactam administered in the study (as instructed by the drug's monograph)", 'armGroupLabels': ['Piperacillin-tazobactam administered in a standard infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J4V 2H1', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital Charles- Le Moyne', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CR-CSSS Champlain-Charles-Le Moyne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Benoit Crevier', 'investigatorAffiliation': 'CR-CSSS Champlain-Charles-Le Moyne'}}}}