A Pilot Study for Optimizing Meropenem Administration in the ICU

NCT05578586 | Recruiting DMC

• 1 other identifier: Meropenem6
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Effect

Outcome Measures

Primary Outcomes (1)

• Concentration above the minimum inhibitory concentration (MIC) ≥ 50 % of the time (2 mg/l)

  Comparing 2 ways of administering meropenem intravenously

  After 24, 48 and 72 hours

Study Arms (2)

Experimental vs Control

EXPERIMENTAL

The patients who are randomized to receive meropenem 1 gram 6 times daily in 15 minutes infusions.

Drug: Meropenem 1000 mg

Controls

ACTIVE COMPARATOR

The patients who are randomized to receive meropenem 2 gram 3 times daily in 3 hours infusions.

Drug: Meropenem 1000 mg

Interventions

Meropenem 1000 mg DRUG

given as 6 or 3 infusions in 15 minues or 3 hours.

Also known as: Meropenem 2000 mg

Controls; Experimental vs Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• with known hypersensistivity to betalactam antibiotics or
• who use of valproat or
• who are pregnant or
• the lack of consent.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0242, Norway

RECRUITING

Related Publications (15)

• Turnidge JD. The pharmacodynamics of beta-lactams. Clin Infect Dis. 1998 Jul;27(1):10-22. doi: 10.1086/514622.

  PMID: 9675443 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 24429437 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 27655029 RESULT

• 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.

  PMID: 21440486 RESULT

• 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.

  PMID: 26974879 RESULT

• 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.

  PMID: 19384201 RESULT

• 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.

  PMID: 23074314 RESULT

• 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.

  PMID: 24657044 RESULT

• 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.

  PMID: 29954243 RESULT

MeSH Terms

Interventions

Meropenem

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ingvild Nordøy, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingvild Nordøy, PhD

CONTACT

+4793028084; inordoy@ous-hf.no

Trine Kåsine, PhD

CONTACT

+4790779669; trikaa@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant, MD, PhD

Model Details: Prospective randomized pilotstudy 1:1.

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 13, 2022
• Study Start: December 14, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)