NCT03529617

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

8.8 years

First QC Date

May 7, 2018

Last Update Submit

July 2, 2024

Conditions

PharmacokineticsLiposomal Amphotericin BCritically Ill Patients

Outcome Measures

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.

    July 2020

Secondary Outcomes (1)

  • Covariates

    July 2020

Study Arms (2)

Critically ill patients

Patients admitted on ICU.

Other: Sample collection

Hematology patients

Patients admitted on the hematology ward.

Other: Sample collection

Interventions

Sample collectionOTHER

Plasma, urine, BAL and ascitic fluid sample collection.

Critically ill patientsHematology patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Treatment with L-AmB
  • Admitted to an ICU or Hematology ward

You may not qualify if:

  • DNR 2 or 3
  • Pregnant or lactating women
  • Previous documentation of intolerance/sensitivity to L-AmB

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood (plasma) Urine BAL (bronchoalveolar lavage) Ascitic fluid

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Isabel Spriet, PharmD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth Van Daele, PharmD

CONTACT

+3216343264ruth.vandaele@uzleuven.be

Isabel Spriet, PharmD, PhD

CONTACT

+3216341261isabel.spriet@uzleuven.be

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2018

First Posted

May 18, 2018

Study Start

October 19, 2016

Primary Completion

July 31, 2025

Study Completion

December 31, 2025

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations

BE(1)