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

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03529617
• Other study ID #: S59273
• Status: Recruiting
• Start date: October 19, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Ruth Van Daele, PharmD
• Phone: +3216343264
• Email: ruth.vandaele[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Patients
• Liposomal Amphotericin B
• Pharmacokinetics

Intervention

Other:
• Sample collection
Plasma, urine, BAL and ascitic fluid sample collection.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	July 2020
Secondary	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.	July 2020