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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Treatment with L-AmB

Admitted to an ICU or Hematology ward

Disqualifiers

DNR 2 or 3

Pregnant or lactating women

Previous documentation of intolerance/sensitivity to L-AmB

Trial population

1. critically ill patients treated with L-AmB 2. hematology patients treated with L-AmB

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Sample collection

    Other intervention

    Plasma, urine, BAL and ascitic fluid sample collection.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Critically ill patients1 intervention
Group B: Hematology patients1 intervention

Trial outcomes

Primary outcomes

1

Plasma exposure and PK parameters

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.

Time frame
July 2020

Secondary outcomes

1

Covariates

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

Time frame
July 2020

Other outcomes

Sponsors and contacts

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