A pilot study for optimizing meropenem administration in the intensive care unit – short six times vs. prolonged three times courses daily

Phase 3

Not yet recruiting

• Conditions: Serious infection requiring broad-spectrum antibiotic

• Registration Number: 2024-520030-30-00
• Lead Sponsor: Oslo University Hospital HF

Brief Summary

The main objective is to demonstrate that meropenem given as 1 g in 15 minutes infusions 6 times daily is as good as the recommended dosing 2 g given during 3 hours 3 times daily.

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 Timeline

• Study First Posted: 2025-01-23
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1. Participants must be 18 years of age at inclusion to give informed consent

The participant must be admitted to the Intensive Care Unit at Oslo University Hospital, Rikshospitalet

The participant must have a condition with confirmed or suspected serious infection

There is indication for treatment with meropenem for at least 3 days

The patient or next of kin must give informed consent to participate in the study

Both genders can be included in the study. Fertile women , all women in the study who are not menopausal, i.e. over 12 months since last menstruation, must use contraception or a pregnancy test must be performed.

If the patient is awake and mentally orientated, the patient shall be asked for consent. If the patient is not able to consent due to sedation, intubation or the like, next of kin will be asked for consent, which may be delayed until the next day.

Exclusion Criteria

If the participant has known hypersensitivity to meropenem or some of the additives to this drug or other drugs of the betalactam group of antibiotics.

If the patient are also treated with valproicacid/sodiumvalproat/valpromid, the participant shal be excluded from the study as these drugs increase the treshold for seizures.

If a women is pregnant, she cannot be included in the study. Fertile women must use contraceptives or have a negative pregnancy test to be included. Postmenopausal women, i.e. > 12 months since last menstruation, can be included.

With the lack of informed consent after Day 1 after inclusion in the study, the patient cannot be included in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients who achieve adequate meropenem concentration (>2 mg/l) > 50% of the time per day (50% T>MIC) when dosing with more frequent and shorter infusions after 1, 2 and 3 days		Proportion of patients who achieve adequate meropenem concentration (>2 mg/l) > 50% of the time per day (50% T>MIC) when dosing with more frequent and shorter infusions after 1, 2 and 3 days

Secondary Outcome Measures

Name	Time	Method
Proportion of patients who achieve adequate meropenem concentration (>2 mg/l) > 100% of the time per day (50% T>MIC) when dosing with more frequent and shorter infusions after 1, 2 and 3 days		Proportion of patients who achieve adequate meropenem concentration (>2 mg/l) > 100% of the time per day (50% T>MIC) when dosing with more frequent and shorter infusions after 1, 2 and 3 days
Lenght of stay in the intensive care unit.		Lenght of stay in the intensive care unit.
Mortality 30 days after admission to the intensive care unit.		Mortality 30 days after admission to the intensive care unit.
Serious adverse events		Serious adverse events

Trial Locations

Locations (1)

Oslo University Hospital HF; 🇳🇴 Oslo, Norway

Oslo University Hospital HF

🇳🇴Oslo, Norway

Ingvild Nordøy

Site contact

+4723071916

inordoy@ous-hf.no