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

March 16, 2026 updated by: Benoit Crevier, CR-CSSS Champlain-Charles-Le Moyne

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of adherence to the sampling protocol
Time Frame: At 24 hours of treatment of piperacillin-tazobactam after randomization
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
Time Frame: At the randomization
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
Time Frame: At the randomization
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
Time Frame: From the screening period to the enrollment, assessed up to 24 hours after the start of a piperacillin-tazobactam prescription
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: At 24 hours of treatment of piperacillin-tazobactam after randomization
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
Time Frame: From enrollment to the last dose of the intervention, assessed up to 42 days
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
Time Frame: From enrollment to the last dose of the intervention, assessed up to 42 days
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
Time Frame: From enrollment to the last dose of the intervention, assessed up to 42 days
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
Time Frame: From enrollment to the last dose of the intervention, assessed up to 42 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CR-CSSS Champlain-Charles-Le Moyne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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