MedTrace Logo

Population Pharmacokinetic Modeling to Optimize the Dosage of the Piperacillin / Tazobactam Combination in Patients With Sepsis in Intensive Care

NCT03748095 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 91

Last updated 2026-06-29

No results posted yet for this study

Summary

Population pharmacokinetic modeling mathematically describes the pharmacokinetics of a drug and the variables likely to influence it in a "typical" patient population. We propose to model a Bayesian estimator, taking into account the individual factors that influence exposure to the piperacillin / tazobactam combination in a target population of sepsis, to allow for early assessment of serum Piperacillin / Tazobactam concentration profiles. optimization of dosing regimens. Indeed, pharmacokinetic tools of this type are already regularly successfully applied for other classes of antibiotics or immunosuppressants whose therapeutic index is narrow. They reduce the toxic risk and optimize the effectiveness of these treatments.

Conditions

  • Resuscitation Patients With Sepsis

Interventions

DRUG

Sparse Pharmacokinetic Sampling Cohort

For the last 30 patients, blood samples of 2 mL collected in dry tubes at T0, T6h (if administered every 6 hours) or T8h (if administered every 8 hours), then T24h, T48h, and T120h after initiation of treatment via 3-hour infusions.

DRUG

Intensive Pharmacokinetic Sampling Cohort

For the first 60 patients, blood samples were collected in 2-mL dry tubes at T0, 90 min, 3 h, 4 h, 5 h, 6 h, 12 h, 24 h, 48 h, and 120 h if infusions are administered over 3 hours every 6 hours; or at T0, 90 min, 3 h, 4 h, 6 h, 8 h, 16 h, 24 h, 48 h, and 120 h if infusions are administered over 3 hours every 8 hours, for piperacillin/tazobactam concentration measurement.

Sponsors & Collaborators

  • University Hospital, Rouen

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-12
Primary Completion
2023-09-12
Completion
2023-09-12

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03748095 on ClinicalTrials.gov