Variability of Fluconazole Concentration in Critically Ill Patients

Fluconazole is the first-line agent in the treatment of invasive candidiasis. Studies showed inappropriate drug exposure causes high mortality in critically ill patients. Under-dosing and ineffective fluconazole trough serum concentrations were found in a recent retrospective study. Variability in fluconazole exposure can be easily measured with therapeutic drug monitoring. For patient groups who are at risk for drug underexposure, therapeutic drug monitoring can be valuable regards decreasing mortality.

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Key information

Conditions

Invasive Candidiasis Bacterial Infections and Mycoses Candidiasis Candidiasis, Invasive Infections Invasive Fungal Infections Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patient is 18 years or older.
Treatment with fluconazole.
Written informed consent obtained from patient.
Written informed consent obtained from representative of patient.

Exclusion criteria

Blood sampling not possible

Treatment and study plan

Primary outcomes

Plasma concentrations of fluconazole in critically ill patients

Time frame: Up to one month

Plasma concentrations of fluconazole will be determined using a validated method involving LC-MS/MS

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Fluconazole Exposure in Critically Ill Patients and the Value of Therapeutic Drug Monitoring

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jul 7, 2015
Registry last updated: May 3, 2017

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.

Published trials that share one or more normalized conditions with this study.

Completed