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MER6: A Pilot Study for Optimizing Meropenem Administration in the ICU

Sponsor
Oslo University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05578586
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
35.6
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Meropenem 1000 mg
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective randomized pilotstudy 1:1.Prospective randomized pilotstudy 1:1.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study for Optimizing Meropenem Administration in the Intensive Care Unit - Short Six Times vs Prolonged Three Times Courses Daily
Actual Study Start Date :
Dec 14, 2021
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Concentration above the minimum inhibitory concentration (MIC) ≥ 50 % of the time (2 mg/l) [After 24, 48 and 72 hours]

      Comparing 2 ways of administering meropenem intravenously

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oslo University Hospital Oslo Norway 0242

    Sponsors and Collaborators

    • Oslo University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ingvild Nordøy, Senior consultant, MD, PhD, Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT05578586
    Other Study ID Numbers:
    • Meropenem6
    First Posted:
    Oct 13, 2022
    Last Update Posted:
    Oct 18, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Meropenem

    Study Results

    No Results Posted as of Oct 18, 2022