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.

Study Overview

• Status: Unknown
• Conditions: Pharmacokinetics; Critically Ill Patients; Liposomal Amphotericin B
• Intervention / Treatment: Other: Sample collection

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Ruth Van Daele, PharmD; Phone Number: +3216343264; Email: ruth.vandaele@uzleuven.be
• Study Contact Backup: Name: Isabel Spriet, PharmD, PhD; Phone Number: +3216341261; Email: isabel.spriet@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Ruth Van Daele, PharmD; Phone Number: +3216343264; Email: ruth.vandaele@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Critically ill patients; Patients admitted on ICU.	Other: Sample collection; Plasma, urine, BAL and ascitic fluid sample collection.
Hematology patients; Patients admitted on the hematology ward.	Other: Sample collection; Plasma, urine, BAL and ascitic fluid sample collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: KU Leuven
• Investigators: Principal Investigator: Isabel Spriet, PharmD, PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2016
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 7, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: S59273

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No