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Completed

NCT Number: NCT04252027

Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients

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

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Key information

Conditions

Critically Ill Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • < 18 years
  • DNR 2 or 3

Treatment and study plan

Sample collection

Other

Plasma and urine sample collection

Primary outcomes

  1. Exposure to fluconazole (trough levels)

    Time frame: On the day of sampling

    To document the trough levels (Cmin) of fluconazole in an ICU cohort over multiple days of treatment

  2. Exposure to fluconazole (trough levels)

    Time frame: June 2020

    Determine if the Cmin target levels are attained.

Secondary outcomes

  1. Variability in fluconazole trough levels

    Time frame: June 2020

    To determine the intra-and intersubject variability of the fluconazole trough levels

  2. Influencing covariates

    Time frame: June 2020

    Determine possible covariates that might explain the fluconazole variability

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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