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

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Liposomal Amphotericin B; Critically Ill Patients; Pharmacokinetics

Treatments: Other: Sample collection

Study type: Observational

Funder types: Other

Identifiers

NCT03529617

S59273

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

Critically ill patients

Description:

Patients admitted on ICU.

Treatment:

Other: Sample collection

Hematology patients

Description:

Patients admitted on the hematology ward.

Treatment:

Other: Sample collection