Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT04252027
Collaborator
KU Leuven (Other)
43
1
10.4
4.1

Study Details

Study Description

Brief Summary

This prospective study will research the exposure and its variability to fluconazole after longitudinal administration in critically ill patients

Condition or Disease Intervention/Treatment Phase
  • Other: Sample collection

Detailed Description

An open label, monocenter pharmacokinetic study will be carried out in critically ill patients, admitted at the University Hospitals Leuven, receiving multiple dose treatment with fluconazole.

The exposure to fluconazole in the ICU cohort over multiple days of treatment will be documented. Moreover, variability and the correlating covariates that can influence the fluconazole concentration, will be determined.

Study Design

Study Type:
Observational
Actual Enrollment :
43 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients: a Longitudinal Follow-up of Trough Levels
Actual Study Start Date :
Apr 23, 2019
Actual Primary Completion Date :
Mar 5, 2020
Actual Study Completion Date :
Mar 5, 2020

Outcome Measures

Primary Outcome Measures

  1. Exposure to fluconazole (trough levels) [On the day of sampling]

    To document the trough levels (Cmin) of fluconazole in an ICU cohort over multiple days of treatment

  2. Exposure to fluconazole (trough levels) [June 2020]

    Determine if the Cmin target levels are attained.

Secondary Outcome Measures

  1. Variability in fluconazole trough levels [June 2020]

    To determine the intra-and intersubject variability of the fluconazole trough levels

  2. Influencing covariates [June 2020]

    Determine possible covariates that might explain the fluconazole variability

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 18 years

  • Treatment with fluconazole

  • Admitted to an ICU ward

Exclusion Criteria:
  • < 18 years

  • DNR 2 or 3

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Leuven Leuven Belgium 3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven
  • KU Leuven

Investigators

  • Principal Investigator: Isabel Spriet, PharmD, PhD, UZ Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT04252027
Other Study ID Numbers:
  • S62242
First Posted:
Feb 5, 2020
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Universitaire Ziekenhuizen Leuven
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2021