drugset / Trial / NCT05578586
A Pilot Study for Optimizing Meropenem Administration in the ICU
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-12-14
- Primary completion
- 2026-12
- Completion
- 2027-06
Publications
- Results Turnidge JD. The pharmacodynamics of beta-lactams. Clin Infect Dis. 1998 Jul;27(1):10-22. doi: 10.1086/514622.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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 2014 Jan 14.
- Results 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.
- Results 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.
- Results Petersson J, Giske CG, Eliasson E. Standard dosing of piperacillin and meropenem fail to achieve adequate plasma concentrations in ICU patients. Acta Anaesthesiol Scand. 2016 Nov;60(10):1425-1436. doi: 10.1111/aas.12808. Epub 2016 Sep 21.
- Results Mouton JW, Ambrose PG, Canton R, Drusano GL, Harbarth S, MacGowan A, Theuretzbacher U, Turnidge J. Conserving antibiotics for the future: new ways to use old and new drugs from a pharmacokinetic and pharmacodynamic perspective. Drug Resist Updat. 2011 Apr;14(2):107-17. doi: 10.1016/j.drup.2011.02.005. Epub 2011 Mar 26.
- Results Roberts JA, Abdul-Aziz MH, Davis JS, Dulhunty JM, Cotta MO, Myburgh J, Bellomo R, Lipman J. Continuous versus Intermittent beta-Lactam Infusion in Severe Sepsis. A Meta-analysis of Individual Patient Data from Randomized Trials. Am J Respir Crit Care Med. 2016 Sep 15;194(6):681-91. doi: 10.1164/rccm.201601-0024OC.
- Results Roberts JA, Webb S, Paterson D, Ho KM, Lipman J. A systematic review on clinical benefits of continuous administration of beta-lactam antibiotics. Crit Care Med. 2009 Jun;37(6):2071-8. doi: 10.1097/CCM.0b013e3181a0054d.
- Results Falagas ME, Tansarli GS, Ikawa K, Vardakas KZ. Clinical outcomes with extended or continuous versus short-term intravenous infusion of carbapenems and piperacillin/tazobactam: a systematic review and meta-analysis. Clin Infect Dis. 2013 Jan;56(2):272-82. doi: 10.1093/cid/cis857. Epub 2012 Oct 16.
- Results Teo J, Liew Y, Lee W, Kwa AL. Prolonged infusion versus intermittent boluses of beta-lactam antibiotics for treatment of acute infections: a meta-analysis. Int J Antimicrob Agents. 2014 May;43(5):403-11. doi: 10.1016/j.ijantimicag.2014.01.027. Epub 2014 Mar 1.
- Results Ahmed N, Jen SP, Altshuler D, Papadopoulos J, Pham VP, Dubrovskaya Y. Evaluation of Meropenem Extended Versus Intermittent Infusion Dosing Protocol in Critically Ill Patients. J Intensive Care Med. 2020 Aug;35(8):763-771. doi: 10.1177/0885066618784264. Epub 2018 Jun 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Meropenem | Small molecule | 1000 mg | Intravenous |
| Subject | Meropenem | Small molecule | 2000 mg | Intravenous |
Indications
No indication recorded.