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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-26

Study Completion Date

2025-12-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Infections Obesity and Obesity-related Medical Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Piperacillin-tazobactam administered in a prolonged infusion

Intervention Type DRUG

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.

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)

Group Type ACTIVE_COMPARATOR

Piperacillin-tazobactam administered in a standard infusion

Intervention Type DRUG

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)

Interventions

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Piperacillin-tazobactam administered in a prolonged infusion

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.

Intervention Type DRUG

Piperacillin-tazobactam administered in a standard infusion

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)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No