A Pilot Study for Optimizing Meropenem Administration in the ICU (MER6)
Primary Purpose
Drug Effect
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Meropenem 1000 mg
Sponsored by
About this trial
This is an interventional treatment trial for Drug Effect
Eligibility Criteria
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.
Sites / Locations
- Oslo University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental vs Control
Controls
Arm Description
The patients who are randomized to receive meropenem 1 gram 6 times daily in 15 minutes infusions.
The patients who are randomized to receive meropenem 2 gram 3 times daily in 3 hours infusions.
Outcomes
Primary Outcome Measures
Concentration above the minimum inhibitory concentration (MIC) ≥ 50 % of the time (2 mg/l)
Comparing 2 ways of administering meropenem intravenously
Secondary Outcome Measures
Full Information
NCT ID
NCT05578586
First Posted
October 11, 2022
Last Updated
October 15, 2022
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05578586
Brief Title
A Pilot Study for Optimizing Meropenem Administration in the ICU
Acronym
MER6
Official Title
A Pilot Study for Optimizing Meropenem Administration in the Intensive Care Unit - Short Six Times vs Prolonged Three Times Courses Daily
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized pilotstudy 1:1.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental vs Control
Arm Type
Experimental
Arm Description
The patients who are randomized to receive meropenem 1 gram 6 times daily in 15 minutes infusions.
Arm Title
Controls
Arm Type
Active Comparator
Arm Description
The patients who are randomized to receive meropenem 2 gram 3 times daily in 3 hours infusions.
Intervention Type
Drug
Intervention Name(s)
Meropenem 1000 mg
Other Intervention Name(s)
Meropenem 2000 mg
Intervention Description
given as 6 or 3 infusions in 15 minues or 3 hours.
Primary Outcome Measure Information:
Title
Concentration above the minimum inhibitory concentration (MIC) ≥ 50 % of the time (2 mg/l)
Description
Comparing 2 ways of administering meropenem intravenously
Time Frame
After 24, 48 and 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ingvild Nordøy, PhD
Phone
+4793028084
Email
inordoy@ous-hf.no
First Name & Middle Initial & Last Name or Official Title & Degree
Trine Kåsine, PhD
Phone
+4790779669
Email
trikaa@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingvild Nordøy, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0242
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingvild Nordøy, PhD
Phone
+4793028084
Email
inordoy@ous-hf.no
First Name & Middle Initial & Last Name & Degree
Trine Kåsine, PhD
Phone
+4790779669
Email
trikka@ous-hf.no
12. IPD Sharing Statement
Plan to Share IPD
No
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A Pilot Study for Optimizing Meropenem Administration in the ICU
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