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Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients

Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients: a Longitudinal Follow-up of Trough Levels

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04252027
Enrollment
43
Registered
2020-02-05
Start date
2019-04-23
Completion date
2020-03-05
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill Patients

Keywords

Pharmacokinetics, Fluconazole, Variability, Target attainment

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.

Interventions

OTHERSample collection

Plasma and urine sample collection

Sponsors

KU Leuven
CollaboratorOTHER
Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \> 18 years * Treatment with fluconazole * Admitted to an ICU ward

Exclusion criteria

* \< 18 years * DNR 2 or 3

Design outcomes

Primary

MeasureTime frameDescription
Exposure to fluconazole (trough levels)On the day of samplingTo document the trough levels (Cmin) of fluconazole in an ICU cohort over multiple days of treatment

Secondary

MeasureTime frameDescription
Variability in fluconazole trough levelsJune 2020To determine the intra-and intersubject variability of the fluconazole trough levels
Influencing covariatesJune 2020Determine possible covariates that might explain the fluconazole variability

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026