Piperacillin-Tazobactam Infusion Methods for Infections in Obesity

Overseen By Benoît Crevier, PharmD., MSc., BCCCP

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: CR-CSSS Champlain-Charles-Le Moyne

Must be taking: Piperacillin-tazobactam

Must not be taking: Antiepileptic drugs

Disqualifiers: Renal therapy, Pregnancy, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 42 days

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with obesity who may have infections. It's designed to see if a longer infusion of the antibiotic piperacillin-tazobactam works better than the standard way it's given. Participants must meet certain health criteria, but specific inclusion and exclusion details are not provided.

Inclusion Criteria

My BMI is 30 or higher.

Patients hospitalized at Hôpital Charles-Le Moyne

I am scheduled for a treatment with piperacillin-tazobactam for at least 24 hours.

Exclusion Criteria

I am on dialysis or other kidney replacement therapy.

Pregnancy

Documented allergy to beta-lactams of the penicillin class

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 24 hours

Treatment

Participants receive piperacillin-tazobactam administered as either a prolonged intermittent infusion or a standard infusion

Up to 42 days

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Piperacillin-Tazobactam

Trial Overview The study tests whether administering piperacillin-tazobactam as a prolonged infusion is more effective in patients with obesity compared to the standard short-term infusion method. The goal is to maintain effective drug levels in the body for fighting infection.

Participant Groups

Group I: Piperacillin-tazobactam administered in a prolonged infusion Experimental Treatment 1 Intervention

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.

Group II: Piperacillin-tazobactam administered in a standard infusion Active Control 1 Intervention

Piperacillin-tazobactam dose will be administered over 30 minutes for every piperacilline-tazobactam administered in the study (as instructed by the drug's monograph)

Who Is Running the Clinical Trial?

CR-CSSS Champlain-Charles-Le Moyne

Lead Sponsor

Trials

7

Recruited

510+