CClinicalTrials.gg
Status unknownNCT05134298Updated Nov 24, 2021

Pharmacokinetics of Piperacillin and Meropenem in ICU Patients

An observational study in Antibiotic Pharmacokinetics, sponsored by Karolinska University Hospital. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-24.

Sponsored by Karolinska University Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Antibiotic Pharmacokinetics
03

In context

Lead sponsor

Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

ICU-patients.

Eligibility criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Study Kohort

    As specified by study population, inclusion and exclusion criteria

    Drug: Piperacillin/tazobactam, Meropenem

Interventions

  • DrugPiperacillin/tazobactam, Meropenem

    This is an observational study exploring the antibiotic plasma concentration profiles in ICU paitents after the first drug administration.

06

What researchers measure

Primary outcomes

  1. Volume of distribution

    Apparent volume of distribution calculated from repeated plasma concentrations measurements and pharmacokinetic modelling.

    Time frame: For the first antibiotic administration and if possible for a second administration 48-72 hour later.

  2. Plasma clearance

    Plasma clearance calculated from repeated plasma concentrations measurements and pharmacokinetic modelling.

    Time frame: For the first antibiotic administration and if possible for a second administration 48-72 hour later.

Secondary outcomes

  1. Plasma antibiotic concentrations at mid and end of dosing interval

    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.

07

Study locations

1 of 1 sites recruiting
  • Karolinska University Hospital
    Stockholm, 17176, Sweden
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05134298
Lead sponsor
Karolinska University Hospital
Responsible party
Johan Petersson (Senior ICU consultant, Associate Professor, Karolinska University Hospital) — Principal investigator
First posted
Nov 24, 2021
Start date
Nov 1, 2019
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Nov 24, 2021

Study contacts

Johan Petersson, MD, Ass Prof
Contact
johan.petersson@sll.se
+46-8-51770000
Erik Eliasson, MD, Prof
Contact
erik.eliasson@ki.se
+46-8-51770000

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion