Piperacillin-Tazobactam Infusion Methods for Infections in Obesity

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: CR-CSSS Champlain-Charles-Le Moyne

No Placebo Group

Prior Safety Data

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.

+2 more

Exclusion Criteria

I am on dialysis or other kidney replacement therapy.

Pregnancy

Documented allergy to beta-lactams of the penicillin class

+2 more

Trial 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

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Piperacillin-tazobactam administered in a prolonged infusionExperimental Treatment1 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 infusionActive Control1 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)