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NCT Number: NCT03529617

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

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.

Recruiting

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Key information

Conditions

Pharmacokinetics Critically Ill Patients Liposomal Amphotericin B

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sample collection

Other

Plasma, urine, BAL and ascitic fluid sample collection.

Primary outcomes

  1. Plasma exposure and PK parameters

    Time frame: 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 outcomes

  1. Covariates

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Isabel Spriet, PharmD, PhD

CONTACT

[email protected]

+3216341261

Ruth Van Daele, PharmD

CONTACT

[email protected]

+3216343264

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
May 18, 2018
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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