Pharmacokinetics of Piperacillin and Meropenem in ICU Patients

November 23, 2021 updated by: Johan Petersson, Karolinska University Hospital

First Dose Pharmacokinetics for Piperacillin and Meropenem in ICU Patients

The purpose of the study is to characterize the pharmacokinetics of meropenem and piperacillin in ICU-patients at the time of the first dose administration and to contrast that with the same measurements obtained in the same patient 2-3 days later during the course of ICU treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

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 Backup

Study Locations

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ICU-patients.

Description

Inclusion Criteria:

- Patient being treated in one of the participating ICUs and planned to recieve treatment with meropenem or piperacillin.

Exclusion Criteria (fullfilling any exlusion criteria means that patient cannot be included in the study):

  • Not possible to retrospectively ask the patient or next of kin for consent to take part in the study or patient or next-of-kin not providing consent.
  • Not posisble to obtain and process blood samples as specified by protocol.
  • Ongoing renal replacement therapy.
  • Patient having received the same antibiotic within the previous 96 h.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Kohort
As specified by study population, inclusion and exclusion criteria
Drug: Piperacillin/tazobactam, Meropenem
This is an observational study exploring the antibiotic plasma concentration profiles in ICU paitents after the first drug administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of distribution
Time Frame: For the first antibiotic administration and if possible for a second administration 48-72 hour later.
Apparent volume of distribution calculated from repeated plasma concentrations measurements and pharmacokinetic modelling.
For the first antibiotic administration and if possible for a second administration 48-72 hour later.
Plasma clearance
Time Frame: For the first antibiotic administration and if possible for a second administration 48-72 hour later.
Plasma clearance calculated from repeated plasma concentrations measurements and pharmacokinetic modelling.
For the first antibiotic administration and if possible for a second administration 48-72 hour later.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma antibiotic concentrations at mid and end of dosing interval
Time Frame: For the first antibiotic administration and if possible for a second administration 48-72 hour later.
Plasma antibiotic concentrations at mid and end of dosing interval
For the first antibiotic administration and if possible for a second administration 48-72 hour later.

Collaborators and Investigators

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

Sponsor

Karolinska University Hospital

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)

November 1, 2019

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

November 23, 2021

First Posted (ACTUAL)

November 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 24, 2021

Last Update Submitted That Met QC Criteria

November 23, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K 2018-6443

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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