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

Evaluation of the Achievement of a Pharmacodynamic Target of Piperacillin-Tazobactam for the Population With Obesity: an Open Randomized Controlled Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Infections; Obesity and Obesity-related Medical Conditions
• Intervention / Treatment: Drug: Piperacillin-tazobactam administered in a prolonged infusion; Drug: Piperacillin-tazobactam administered in a standard infusion

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Hôpital Charles- Le Moyne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients reaching the target of fT>MIC equal to 100% after 24 hours of piperacillin-tazobactam according to the assigned intervention	Proportion of patients reaching the target of the time the free concentration of the drug remains above the MIC during the dosing interval (i.e. 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	Evaluate the 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	Assess if there has been an escalation to carbapenem antibiotics	From enrollment to the last dose of the intervention, assessed up to 42 days
Incidence of adverse events attributed to the intervention	Evaluate the incidence of adverse effects 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	Evaluate the number of days until de-escalation to a narrower spectrum injectable antibiotic or to an oral switch, if necessary	From enrollment to the last dose of the intervention, assessed up to 42 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): November 27, 2025

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Pharmacodynamics; Piperacillin-tazobactam
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Infections; Anti-Bacterial Agents; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; beta-Lactamase Inhibitors; Tazobactam; Piperacillin, Tazobactam Drug Combination; Piperacillin
• Other Study ID Numbers: 2025-956

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No