NCT05578586

A Pilot Study for Optimizing Meropenem Administration in the ICU

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Drug Effect

Interventions

Type	Name	Description
DRUG	Meropenem 1000 mg	given as 6 or 3 infusions in 15 minues or 3 hours.

Timeline

• Start date: 2021-12-14
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2022-10-13
• Last updated: 2025-04-24

Locations

1 site across 1 country: Norway