An observational study in Critically Ill Patients, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
This prospective study will research the exposure and its variability to fluconazole after longitudinal administration in critically ill patients
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 43 is below the median of 130 across 867 observational studies indexed under Critical Illness.
Browse Critical Illness studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Critically ill patients.
Exclusion Criteria:
Plasma and urine sample collection
Exposure to fluconazole (trough levels)
To document the trough levels (Cmin) of fluconazole in an ICU cohort over multiple days of treatment
Time frame: On the day of sampling
Exposure to fluconazole (trough levels)
Determine if the Cmin target levels are attained.
Time frame: June 2020
Variability in fluconazole trough levels
To determine the intra-and intersubject variability of the fluconazole trough levels
Time frame: June 2020
Influencing covariates
Determine possible covariates that might explain the fluconazole variability
Time frame: June 2020
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven