A Pilot Study for Optimizing Meropenem Administration in the ICU
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Meropenem 1000 mg.
- Who it may be relevant to
- Registry conditions: Drug Effect. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Study for Optimizing Meropenem Administration in the Intensive Care Unit - Short Six Times vs Prolonged Three Times Courses Daily
Overview
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.
Interventions
- Drug Meropenem 1000 mg
given as 6 or 3 infusions in 15 minues or 3 hours.
Primary outcome measures
- Concentration above the minimum inhibitory concentration (MIC) ≥ 50 % of the time (2 mg/l) [Time frame: After 24, 48 and 72 hours]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Norway · 1 center
- Oslo University Hospital — Oslo
Publications
- Turnidge JD. The pharmacodynamics of beta-lactams. Clin Infect Dis. 1998 Jul;27(1):10-22. doi: 10.1086/514622. PMID 9675443
- Craig WA. Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin Infect Dis. 1998 Jan;26(1):1-10; quiz 11-2. doi: 10.1086/516284. PMID 9455502
- Drusano GL. Antimicrobial pharmacodynamics: critical interactions of 'bug and drug'. Nat Rev Microbiol. 2004 Apr;2(4):289-300. doi: 10.1038/nrmicro862. No abstract available. PMID 15031728
- Roberts JA, Lipman J. Optimizing use of beta-lactam antibiotics in the critically ill. Semin Respir Crit Care Med. 2007 Dec;28(6):579-85. doi: 10.1055/s-2007-996404. PMID 18095221
- De Waele JJ, Lipman J, Carlier M, Roberts JA. Subtleties in practical application of prolonged infusion of beta-lactam antibiotics. Int J Antimicrob Agents. 2015 May;45(5):461-3. doi: 10.1016/j.ijantimicag.2015.01.007. Epub 2015 Feb 16. PMID 25749200
- Roberts JA, Paul SK, Akova M, Bassetti M, De Waele JJ, Dimopoulos G, Kaukonen KM, Koulenti D, Martin C, Montravers P, Rello J, Rhodes A, Starr T, Wallis SC, Lipman J; DALI Study. DALI: defining antibiotic levels in intensive care unit patients: are current beta-lactam antibiotic doses sufficient for critically ill patients? Clin Infect Dis. 2014 Apr;58(8):1072-83. doi: 10.1093/cid/ciu027. Epub 201 PMID 24429437
- Taccone FS, Laterre PF, Dugernier T, Spapen H, Delattre I, Wittebole X, De Backer D, Layeux B, Wallemacq P, Vincent JL, Jacobs F. Insufficient beta-lactam concentrations in the early phase of severe sepsis and septic shock. Crit Care. 2010;14(4):R126. doi: 10.1186/cc9091. Epub 2010 Jul 1. PMID 20594297
- Binder L, Schworer H, Hoppe S, Streit F, Neumann S, Beckmann A, Wachter R, Oellerich M, Walson PD. Pharmacokinetics of meropenem in critically ill patients with severe infections. Ther Drug Monit. 2013 Feb;35(1):63-70. doi: 10.1097/FTD.0b013e31827d496c. PMID 23318279
Identifiers
NCT: NCT05578586 · Meropenem6