Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients

Critically Ill Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04252027
• Other study ID #: S62242
• Status: Completed
• Start date: April 23, 2019
• Est. completion date: March 5, 2020

Study information

• Verified date: April 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 5, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 18 years

• Treatment with fluconazole

• Admitted to an ICU ward

Exclusion Criteria:

• < 18 years

• DNR 2 or 3

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Patients

Intervention

Other:
• Sample collection
Plasma and urine sample collection

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exposure to fluconazole (trough levels)	To document the trough levels (Cmin) of fluconazole in an ICU cohort over multiple days of treatment	On the day of sampling
Primary	Exposure to fluconazole (trough levels)	Determine if the Cmin target levels are attained.	June 2020
Secondary	Variability in fluconazole trough levels	To determine the intra-and intersubject variability of the fluconazole trough levels	June 2020
Secondary	Influencing covariates	Determine possible covariates that might explain the fluconazole variability	June 2020