A Pilot Study for Optimizing Meropenem Administration in the ICU

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Drug Effect

Intervention / Treatment
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* Drug: Meropenem 1000 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized pilotstudy 1:1.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental vs Control<br>The patients who are randomized to receive meropenem 1 gram 6 times daily in 15 minutes infusions. | Drug: Meropenem 1000 mg<br>* given as 6 or 3 infusions in 15 minues or 3 hours.<br>* Other names: Meropenem 2000 mg;|
| Active Comparator: Controls<br>The patients who are randomized to receive meropenem 2 gram 3 times daily in 3 hours infusions. | Drug: Meropenem 1000 mg<br>* given as 6 or 3 infusions in 15 minues or 3 hours.<br>* Other names: Meropenem 2000 mg;|

What is the study measuring?
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Primary Outcome Measures

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