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

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

Recruiting
18 years and older
All
Phase N/A
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Overview

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.

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.

Eligibility

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 details
    Pharmacokinetics
    Liposomal Amphotericin B
    Critically Ill Patients

NCT03529617

Universitaire Ziekenhuizen KU Leuven

15 October 2025

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