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

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

Study Overview

• Status: Completed
• Conditions: Critically Ill Patients
• Intervention / Treatment: Other: Sample collection

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 Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Critically ill patients.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• < 18 years
• DNR 2 or 3

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Exposure to fluconazole (trough levels)	Determine if the Cmin target levels are attained.	June 2020

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: KU Leuven
• Investigators: Principal Investigator: Isabel Spriet, PharmD, PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2019
• Primary Completion (Actual): March 5, 2020
• Study Completion (Actual): March 5, 2020

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Fluconazole; Variability; Target attainment
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: S62242

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No