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NCT03776305

Imipenem in Critically Ill Patients

Status unknown Phase 4 Last updated 15 February 2019
What this trial tests

Phase 4 trial testing Imipenem in Critically Ill Patients With ECMO in 12 participants. Status unknown.

Timeline
1 December 2015
Primary endpoint
1 February 2018
30 December 2020

Quick facts

Lead sponsorPrince of Songkla University
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment12
Start date1 December 2015
Primary completion1 February 2018
Estimated completion30 December 2020
Sites1 location across Thailand

Drugs / interventions tested

Conditions studied

Sponsor

Prince of Songkla University

Who can join

Adults 18 to 90, any sex, with Critically Ill Patients With ECMO. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Extracorporeal membrane oxygenation (ECMO) has become increasingly used for lifesaving respiratory and/or cardiac failure support in critically ill patients, including those with life-threatening severe infections. This cardiopulmonary bypass device has been shown to enhance the profound pathophysiological changes in this patient population, resulting in an alteration of the pharmacokinetics (PK) of antimicrobial agents. The aim of this study was to determine the effect of ECMO on the PK of imipenem in critically ill patients supported by this cardiopulmonary bypass device. Methods The study was conducted in critically ill patients with respiratory and/or cardiac failure and suspected severe nosocomial infections who were supported by ECMO. All patients received a 1-h infusion of 0.5 g of imipenem every 6 h and imipenem PK studies were carried out on the fourth dose of drug administration.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Pharmacokinetics and Monte Carlo Dosing Simulations of Imipenem in Critically Ill Patients with Life-Threatening Severe Infections During Support with Extracorporeal Membrane Oxygenation.
    Jaruratanasirikul S, Vattanavanit V, Wongpoowarak W, Nawakitrangsan M, et al · · 2020 · cited 8× · PMID 32886347 · DOI 10.1007/s13318-020-00643-3

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Other trials of Imipenem

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