Pharmacokinetics of Colistin in Critically Ill Patients With Extracorporeal Membrane Oxygenation

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Anne's University Hospital Brno, Czech Republic
• Collaborator: Palacky University
• Treatments: Colistin

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Men and women (with a negative pregnancy test prior to study enrolment in women of childbearing potential)

• Hospitalized at the Department of Anaesthesiology and Resuscitation, St. Anne´s University Hospital Brno

• Indication for parenteral colistin (or CMS) as part of standard medical care, i.e., in patients with severe bacterial infection

• Informed consent given. In unconscious patients, the study investigator will decide whether to include the patient in the study; this decision is made whenever possible in a medical council consisting of at least one independent physician informed about the study details and one study investigator. An interim informed consent will be given after considering all individual risks. In this case, the Ethics Committee of St. Anne's Hospital in Brno will be informed of the patient's inclusion. The investigator will ask study participants in whom good quality consciousness is restored to give subsequent informed consent without unreasonable delay.

Additional inclusion criterion:

For some patients (15 individuals are expected), in addition to all the criteria listed in the Eligibility Criteria section, the following inclusion criterion is provided:

• ECMO support is needed as part of standard therapy for severe respiratory failure.

Exclusion Criteria:

• Pregnancy,

• Breast-feeding,

• Refusal to give the informed consent (primarily or after regaining consciousness).