A Pilot Study for Optimizing Meropenem Administration in the ICU (MER6)

April 23, 2025 updated by: Ingvild Nordøy, Oslo University Hospital

A Pilot Study for Optimizing Meropenem Administration in the Intensive Care Unit - Short Six Times vs Prolonged Three Times Courses Daily

Can antibiotic drugs be administered faster and make acceptable serum concentrations if we give short but multiple infusions compared to long and fewer infusions? In this study we will compare giving meropenem 1 gram 6 times daily in 15 minutes infusions to the recommended 2 gram 3 times daily in 3 hours infusions. In patients in the intensive care unit, the need for intravenous access is of essence. If 6 short infusions results in the same serum concentrations as 3 long infusions, we will increase intravenous access from 15 to 22.5 hours daily.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary aim of this pilot study is to examine if the dosing of the antibiotic meropenem given as 1 gram 6 times daily in 15 minutes infusions can be compared to 2 grams given 3 times daily in 3 hours infusion when measuring the serum concentration above the minimum inhibitory concentration (MIC) ≥ 50 % of the time (2 mg/l).

The secondary aims are

  • That both administration forms will result in serum concentrations above MIC ≥ 100 % of the time (2 mg/l)
  • Days in hospital
  • 30 days mortality after admittance to the ICU
  • Serious side-effects

Five extra blood samples will be performed 24, 48 and 72 hours between two dosing intervals. The dose will be adjusted according to renal function which will be monitored daily. The patients will be supervised for adverse effects until 2 days after treatment has stopped.

The study will be performed from 2021 to the end of 2024.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

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

  • Norway
      • Oslo, Norway, 0242
        • Recruiting
        • Oslo University Hospital
        • Contact:
        • Contact:

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients ≥ 18 years admitted to the ICU at Oslo University Hospital, Rikshospitalet and
  2. who shall be treated with meropenem because of proven or suspected serious infection and
  3. who give their written informed consent either directly or through next of kin

Exclusion Criteria: Patients

  1. with known hypersensistivity to betalactam antibiotics or
  2. who use of valproat or
  3. who are pregnant or
  4. the lack of consent.

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
Intervention / Treatment
Experimental: Experimental vs Control
The patients who are randomized to receive meropenem 1 gram 6 times daily in 15 minutes infusions.
Drug: Meropenem 1000 mg
given as 6 or 3 infusions in 15 minues or 3 hours.
Other Names:
  • Meropenem 2000 mg
Active Comparator: Controls
The patients who are randomized to receive meropenem 2 gram 3 times daily in 3 hours infusions.
Drug: Meropenem 1000 mg
given as 6 or 3 infusions in 15 minues or 3 hours.
Other Names:
  • Meropenem 2000 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration above the minimum inhibitory concentration (MIC) ≥ 50 % of the time (2 mg/l)
Time Frame: After 24, 48 and 72 hours
Comparing 2 ways of administering meropenem intravenously
After 24, 48 and 72 hours

Collaborators and Investigators

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

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Ingvild Nordøy, PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 14, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

October 11, 2022

First Submitted That Met QC Criteria

October 11, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Meropenem6

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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