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

Recruiting

• Conditions: Liposomal Amphotericin B; Pharmacokinetics; Critically Ill Patients
• Interventions: Other: Sample collection

• Registration Number: NCT03529617
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Study Timeline

• Study Start: 2016-10-19
• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-07
• Study First Posted: 2018-05-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Treatment with L-AmB
• Admitted to an ICU or Hematology ward

Exclusion Criteria

• DNR 2 or 3
• Pregnant or lactating women
• Previous documentation of intolerance/sensitivity to L-AmB

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Critically ill patients	Sample collection	Patients admitted on ICU.
Hematology patients	Sample collection	Patients admitted on the hematology ward.

Primary Outcome Measures

Name	Time	Method
Plasma exposure and PK parameters	July 2020	To document and compare plasma exposure and PK parameters in an ICU vs. non ICU hematology patient cohort in the early and late phase of L-AmB treatment.

Secondary Outcome Measures

Name	Time	Method
Covariates	July 2020	To document correlating covariates and to stimulate the pharmacokinetics of L-AmB to provide a rationale for optimal dosing strategy in critically ill patients.

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium