Variability of Fluconazole Concentration in Critically Ill Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02491151

Enrollment

Registered

2015-07-07

Start date

2014-10-31

Completion date

2016-12-31

Last updated

2017-05-03

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

Conditions

Invasive Candidiasis

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Plasma concentrations of fluconazole in critically ill patients	Up to one month	Plasma concentrations of fluconazole will be determined using a validated method involving LC-MS/MS

Countries

Netherlands

Outcome results