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Beta-lactam antibiotic

Piperacillin-Tazobactam Infusion Methods for Infections in Obesity

Phase 4

Waitlist Available

Research Sponsored by CR-CSSS Champlain-Charles-Le Moyne

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Obesity (as defined by a body mass index of ≥ 30 kg/m^2)

Adults (18 years and older)

Must not have

Patients with renal replacement therapy (hemodialysis, peritoneal dialysis, continuous venovenous hemodiafiltration)

Patients on prolonged intermittent infusion or continuous infusion of piperacillin-tazobactam before randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to the last dose of the intervention, assessed up to 42 days

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will test whether giving a specific antibiotic in a different way to obese patients can lead to better results.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed, antibiotics like piperacillin-tazobactam can cause allergic reactions, gastrointestinal issues such as diarrhea or nausea, headaches, and sometimes more serious effects depending on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is 30 or higher.

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I am 18 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on dialysis or other kidney replacement therapy.

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I am currently receiving piperacillin-tazobactam through an IV.

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I have a history of seizures or epilepsy, currently treated with medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Achievement of a prespecified number of patients recruited per month

Proportion of eligible patients relative to the total population who received a piperacillin-tazobactam for the study period

Rate of adherence to the sampling protocol

+1 more

Secondary study objectives

Incidence of adverse events attributed to the intervention

Need of escalation to carbapenems antibiotics

Number of days of piperacillin-tazobactam treatment under study

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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)

0 / 6Eligibility criteria met