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

NCT06690905 | Completed Phase 4

• 1 other identifier: 2025-956
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infections; Obesity and Obesity-related Medical Conditions

Keywords

Obesity; Piperacillin-tazobactam; Pharmacodynamics

Outcome Measures

Primary Outcomes (4)

• Rate of adherence to the sampling protocol

  Rate of patients whose blood collection takes place 24 hours after the start of administration of piperacillin-tazobactam according to the method of administration assigned during randomization

  At 24 hours of treatment of piperacillin-tazobactam after randomization

• Recruitment rate

  Proportion of patients meeting the eligibility criteria who consent to the study.

  At the randomization

• Achievement of a prespecified number of patients recruited per month

  Achievement of a number of patients recruited per month of 5 to 8 patients

  At the randomization

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

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

  From the screening period to the enrollment, assessed up to 24 hours after the start of a piperacillin-tazobactam prescription

Secondary Outcomes (5)

• Proportion of patients reaching the target of fT>MIC equal to 100% after 24 hours of piperacillin-tazobactam according to the assigned intervention

  At 24 hours of treatment of piperacillin-tazobactam after randomization

• Number of days of piperacillin-tazobactam treatment under study

  From enrollment to the last dose of the intervention, assessed up to 42 days

• Need of escalation to carbapenems antibiotics

  From enrollment to the last dose of the intervention, assessed up to 42 days

• Incidence of adverse events attributed to the intervention

  From enrollment to the last dose of the intervention, assessed up to 42 days

• Number of days until de-escalation to a narrower spectrum injectable antibiotic or to an oral switch

  From enrollment to the last dose of the intervention, assessed up to 42 days

Study Arms (2)

Piperacillin-tazobactam administered in a prolonged infusion

EXPERIMENTAL

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.

Drug: Piperacillin-tazobactam administered in a prolonged infusion

Piperacillin-tazobactam administered in a standard infusion

ACTIVE COMPARATOR

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

Drug: Piperacillin-tazobactam administered in a standard infusion

Interventions

Piperacillin-tazobactam administered in a prolonged infusion 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 prolonged infusion

Piperacillin-tazobactam administered in a standard infusion 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)

Piperacillin-tazobactam administered in a standard infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CR-CSSS Champlain-Charles-Le Moyne: lead

Study Sites (1)

Hôpital Charles- Le Moyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

MeSH Terms

Conditions

Infections; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 15, 2024
• Study Start: February 26, 2025
• Primary Completion: September 1, 2025
• Study Completion: November 27, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)