Evaluation of the Achievement of a Pharmacodynamic Target of Piperacillin-Tazobactam for the Population with Obesity

Phase 4

Recruiting

• Conditions: Infections; Obesity and Obesity-related Medical Conditions
• Interventions: Drug: Piperacillin-tazobactam administered in a standard infusion; Drug: Piperacillin-tazobactam administered in a prolonged infusion

• Registration Number: NCT06690905
• Lead Sponsor: CR-CSSS Champlain-Charles-Le Moyne

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-13
• Study First Posted: 2024-11-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Study Start: 2025-02-26
• Last Update Posted: 2025-02-27
• Primary Completion: 2025-09-27
• Study Completion: 2025-12-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adults (18 years and older)
• Patients hospitalized at Hôpital Charles-Le Moyne
• Obesity (as defined by a body mass index of ≥ 30 kg/m^2)
• Piperacillin-tazobactam prescription initiated within last 24 hours
• Planned duration of piperacillin-tazobactam of 24 hours or more

Exclusion Criteria

• Documented allergy to beta-lactams of the penicillin class
• Patients with renal replacement therapy (hemodialysis, peritoneal dialysis, continuous venovenous hemodiafiltration)
• Pregnancy
• History of seizures or epilepsy, active seizures or epilepsy treated with antiepileptic drug therapy
• Patients on prolonged intermittent infusion or continuous infusion of piperacillin-tazobactam before randomization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Piperacillin-tazobactam administered in a standard infusion	Piperacillin-tazobactam administered in a standard infusion	Piperacillin-tazobactam dose will be administered over 30 minutes for every piperacilline-tazobactam administered in the study (as instructed by the drug's monograph)
Piperacillin-tazobactam administered in a prolonged infusion	Piperacillin-tazobactam administered in a prolonged infusion	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.

Primary Outcome Measures

Name	Time	Method
Achievement of a prespecified number of patients recruited per month	At the randomization	Achievement of a number of patients recruited per month of 5 to 8 patients
Rate of adherence to the sampling protocol	At 24 hours of treatment of piperacillin-tazobactam after randomization	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
Recruitment rate	At the randomization	Proportion of patients meeting the eligibility criteria who consent to the study.
Proportion of eligible patients relative to the total population who received a piperacillin-tazobactam for the study period	From the screening period to the enrollment, assessed up to 24 hours after the start of a piperacillin-tazobactam prescription	Proportion of eligible patients relative to the total population who received a piperacilline-tazobactam for the study period

Secondary Outcome Measures

Name	Time	Method
Proportion of patients reaching the target of fT>MIC equal to 100% after 24 hours of piperacillin-tazobactam according to the assigned intervention	At 24 hours of treatment of piperacillin-tazobactam after randomization	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
Number of days of piperacillin-tazobactam treatment under study	From enrollment to the last dose of the intervention, assessed up to 42 days	Evaluate the number of days of piperacillin-tazobactam treatment under study
Need of escalation to carbapenems antibiotics	From enrollment to the last dose of the intervention, assessed up to 42 days	Assess if there has been an escalation to carbapenem antibiotics
Incidence of adverse events attributed to the intervention	From enrollment to the last dose of the intervention, assessed up to 42 days	Evaluate the incidence of adverse effects attributed to the intervention
Number of days until de-escalation to a narrower spectrum injectable antibiotic or to an oral switch	From enrollment to the last dose of the intervention, assessed up to 42 days	Evaluate the number of days until de-escalation to a narrower spectrum injectable antibiotic or to an oral switch, if necessary

Trial Locations

Locations (1)

Hôpital Charles- Le Moyne; 🇨🇦 Greenfield Park, Quebec, Canada