Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients

Completed

• Conditions: Critically Ill Patients

• Registration Number: NCT04252027
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

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 Timeline

• Study Start: 2019-04-23
• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-02-05
• Primary Completion: 2020-03-05
• Study Completion: 2020-03-05
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• > 18 years
• Treatment with fluconazole
• Admitted to an ICU ward

Exclusion Criteria

• < 18 years
• DNR 2 or 3

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exposure to fluconazole (trough levels)	June 2020	Determine if the Cmin target levels are attained.

Secondary Outcome Measures

Name	Time	Method
Influencing covariates	June 2020	Determine possible covariates that might explain the fluconazole variability
Variability in fluconazole trough levels	June 2020	To determine the intra-and intersubject variability of the fluconazole trough levels

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium