NCT03529617

Pharmacokinetics of Liposomal Amphotericin B in Critically Ill vs. Non-critically Ill Hematological Patients: Exploration of Covariates

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective study will compare the pharmacokinetic exposure to liposomal amphotericin B between critically ill patients and non-critically ill (hematology) patients in an early and late exposure day.

Detailed description

This phase IV, open label, non-randomized, monocenter pharmacokinetic study will be carried out in critically ill and non-critically ill (hematology) patients receiving multiple dose treatment with L-AmB. The pharmacokinetic exposure to liposomal amphotericin B in plasma, urine, BAL and ascitic fluid will be compared between the two population groups in an early and late exposure day. Correlating covariates will be identified to provide a rationale for optimal dosing strategy in critically ill patients.

Conditions

• Pharmacokinetics
• Liposomal Amphotericin B
• Critically Ill Patients

Interventions

Type	Name	Description
OTHER	Sample collection	Plasma, urine, BAL and ascitic fluid sample collection.

Timeline

• Start date: 2016-10-19
• Primary completion: 2025-07-31
• Completion: 2025-12-31
• First posted: 2018-05-18
• Last updated: 2024-07-03

Locations

1 site across 1 country: Belgium