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NCT Number: NCT06690905

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

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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Key information

Conditions

Infections Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity and Obesity-related Medical Conditions Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital Charles- Le Moyne

Greenfield Park, Quebec, J4V 2H1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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)

Primary outcomes

  1. 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

  2. Recruitment rate

    Time frame: At the randomization

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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

CR-CSSS Champlain-Charles-Le Moyne

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 15, 2024
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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