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

U

Universitaire Ziekenhuizen KU Leuven

Status

Unknown

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

Trial contacts and locations

1

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Central trial contact

Isabel Spriet, PharmD, PhD; Ruth Van Daele, PharmD

Data sourced from clinicaltrials.gov

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