Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients
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 |
---|---|---|
|
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
Outcome Measures
Primary Outcome Measures
- 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
- Exposure to fluconazole (trough levels) [June 2020]
Determine if the Cmin target levels are attained.
Secondary Outcome Measures
- Variability in fluconazole trough levels [June 2020]
To determine the intra-and intersubject variability of the fluconazole trough levels
- Influencing covariates [June 2020]
Determine possible covariates that might explain the fluconazole variability
Eligibility Criteria
Criteria
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.- S62242