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NCT02491151 Clinical Trial

Variability of Fluconazole Concentration in Critically Ill Patients

Invasive Candidiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02491151
Other study ID # FLU-14O28
Secondary ID
Status Completed
Phase N/A
First received June 17, 2015
Last updated May 1, 2017
Start date October 2014
Est. completion date December 2016

Study information
Verified date May 2017
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands University Medical Center Groningen Groningen

Sponsors (1)
Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

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