The pharmacodynamics of beta-lactams.
J D Turnidge
https://pubmed.ncbi.nlm.nih.gov/9675443Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05578586
A Pilot Study for Optimizing Meropenem Administration in the Intensive Care Unit - Short Six Times vs Prolonged Three Times Daily Infusions
Led by Oslo University Hospital · Updated on 2025-04-24
50
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether giving the antibiotic meropenem in shorter but more frequent infusions can achieve similar blood levels compared to longer, less frequent infusions in intensive care unit (ICU) patients. The study aims to see if administering 1 gram six times daily in 15-minute infusions matches the serum concentration of the usual 2 grams three times daily in three-hour infusions. This pilot study focuses on optimizing antibiotic dosing to improve intravenous access time in critically ill patients. Participants will be randomly assigned to one of two groups: one receiving meropenem 1 gram six times daily through 15-minute infusions, and the other receiving 2 grams three times daily through three-hour infusions. The dosing will be adjusted based on daily kidney function monitoring. Blood samples will be collected at 24, 48, and 72 hours to measure antibiotic levels, and patients will be observed for side effects during treatment and for two days after. During the study, researchers will monitor serum meropenem concentrations to see if they stay above the minimum inhibitory concentration (MIC) for at least 50% of the time. Additional outcomes include days in the hospital, 30-day mortality after ICU admission, and serious side effects. The study involves daily blood tests and kidney function assessments, with the total study period running from 2021 to mid-2024. Patient safety and treatment adherence will be closely supervised throughout the trial.
CONDITIONS
Brief Title
A Pilot Study for Optimizing Meropenem Administration in the ICU
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older admitted to the ICU at Oslo University Hospital, Rikshospitalet
- Patients who will be treated with meropenem for proven or suspected serious infection
- Patients who provide written informed consent either directly or through next of kin
You will not qualify if you...
- Known allergy to beta-lactam antibiotics
- Current use of valproate
- Pregnancy
- Lack of consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - Up to 3 days
Participants receive meropenem antibiotic infusions either 1 gram six times daily over 15 minutes or 2 grams three times daily over 3 hours. Dose adjustments are made based on daily renal function monitoring. Blood samples are taken at 24, 48, and 72 hours after dosing to measure drug concentration.
Daily visits during treatment for dosing and blood sampling
Follow-up
Duration - 2 days
Participants are monitored for adverse effects for 2 days after treatment has stopped.
Visits for safety monitoring until 2 days post-treatment
Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Norway, 0242
Actively Recruiting
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Research Team
I
Ingvild Nordøy, PhD
T
Trine Kåsine, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men.
W A Craig
https://pubmed.ncbi.nlm.nih.gov/9455502Antimicrobial pharmacodynamics: critical interactions of 'bug and drug'.
George L Drusano
https://pubmed.ncbi.nlm.nih.gov/15031728Optimizing use of beta-lactam antibiotics in the critically ill.
Jason A Roberts, Jeffrey Lipman
https://pubmed.ncbi.nlm.nih.gov/18095221Subtleties in practical application of prolonged infusion of β-lactam antibiotics.
Jan J De Waele, Jeffrey Lipman, Mieke Carlier...
https://pubmed.ncbi.nlm.nih.gov/25749200DALI: defining antibiotic levels in intensive care unit patients: are current β-lactam antibiotic doses sufficient for critically ill patients?
Jason A Roberts, Sanjoy K Paul, Murat Akova...
https://pubmed.ncbi.nlm.nih.gov/24429437Insufficient β-lactam concentrations in the early phase of severe sepsis and septic shock.
Fabio Silvio Taccone, Pierre-François Laterre, Thierry Dugernier...
https://pubmed.ncbi.nlm.nih.gov/20594297Pharmacokinetics of meropenem in critically ill patients with severe infections.
Lutz Binder, Harald Schwörer, Sebastian Hoppe...
https://pubmed.ncbi.nlm.nih.gov/23318279Standard dosing of piperacillin and meropenem fail to achieve adequate plasma concentrations in ICU patients.
J Petersson, C G Giske, E Eliasson
https://pubmed.ncbi.nlm.nih.gov/27655029Conserving antibiotics for the future: new ways to use old and new drugs from a pharmacokinetic and pharmacodynamic perspective.
Johan W Mouton, Paul G Ambrose, Rafael Canton...
https://pubmed.ncbi.nlm.nih.gov/21440486