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

CR-CSSS Champlain-Charles-Le Moyne

Status and phase: Active, not recruiting; Phase 4

Conditions: Obesity and Obesity-related Medical Conditions; Infections

Treatments: Drug: Piperacillin-tazobactam administered in a standard infusion; Drug: Piperacillin-tazobactam administered in a prolonged infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT06690905

2025-956

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Piperacillin-tazobactam administered in a prolonged infusion

Experimental group

Description:

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.

Treatment:

Drug: Piperacillin-tazobactam administered in a prolonged infusion

Piperacillin-tazobactam administered in a standard infusion

Active Comparator group

Description:

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

Treatment:

Drug: Piperacillin-tazobactam administered in a standard infusion