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NCT Number: NCT05578586

A Pilot Study for Optimizing Meropenem Administration in the ICU

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.

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Key information

Conditions

Drug Effect

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

Patients

  • with known hypersensistivity to betalactam antibiotics or
  • who use of valproat or
  • who are pregnant or
  • the lack of consent.

Treatment and study plan

Meropenem 1000 mg

Drug

given as 6 or 3 infusions in 15 minues or 3 hours.

Other names: Meropenem 2000 mg

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ingvild Nordøy, PhD

CONTACT

[email protected]

+4793028084

Trine Kåsine, PhD

CONTACT

[email protected]

+4790779669

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Acronym: MER6

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Oct 13, 2022
Registry last updated
Apr 24, 2025

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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