Pharmacokinetics of Colistin in Critically Ill Patients With Extracorporeal Membrane Oxygenation — COL-ECMO2022  

Colistin Clinical Trial

Official title: Pharmacokinetics of Colistin in Critically Ill Patients With Extracorporeal Membrane Oxygenation

Status Terminated

Clinical Trial Summary

Colistin is a lipopeptide antibiotic administered as an inactive prodrug - colistin methanesulfonate (CMS). Colistin is a drug with a narrow therapeutic window; the limiting factors are mainly nephrotoxicity and neurotoxicity dependent on plasma concentrations. The number of patients with these types of infections, as well as the number of patients requiring extracorporeal membrane oxygenation (ECMO) support for severe respiratory failure, increased significantly in association with COVID-19-induced infections. ECMO can generally affect the pharmacokinetics of drugs by creating a new compartment.

Clinical Trial Description

The COL-ECMO2022 study is a prospective, non-randomized, open-label single-center, phase IV clinical trial that is designed to assess the influence of ECMO on the pharmacokinetics of colistin and CMS. The study is planned to include up to 30 patients with indication of colistin who will be assigned to one of two arms in a 1:1 ratio depending on the presence/absence of ECMO. All study participants will receive colistin standard, approved dose schedule intravenously. The plasma concentrations of colistin and CMS took at defined intervals will be assessed by high-performance liquid chromatography-mass spectrometry. Patients will participate in the clinical trial for a maximum of three monitored dosing intervals.

Discussion: This study is expected to provide essential evidence-based data on the impact of ECMO on colistin pharmacokinetics in critically ill patients as well as to shed some light on how to optimize the colistin dosing for critically ill patients on ECMO by designing the population model. ;

Related Conditions & MeSH terms

• Colistin
• Critical Illness

• NCT number: NCT05542446
• Study type: Interventional
• Source: St. Anne's University Hospital Brno, Czech Republic
• Status: Terminated
• Phase: Phase 4
• Start date: September 1, 2022
• Completion date: January 19, 2024