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Variability of Fluconazole Concentration in Critically Ill Patients

Sponsor
University Medical Center Groningen (Other)
Overall Status
Completed
CT.gov ID
NCT02491151
Collaborator
(none)
50
Enrollment
1
Location
26
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Fluconazole Exposure in Critically Ill Patients and the Value of Therapeutic Drug Monitoring
    Study Start Date :
    Oct 1, 2014
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    Dec 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Center Groningen Groningen Netherlands

    Sponsors and Collaborators

    • University Medical Center Groningen

    Investigators

    • Principal Investigator: Jan-WIllem Alffenaar, PharmD PhD, University Medical Center Groningen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jan-Willem C Alffenaar, Associate Professor of Medicine, University Medical Center Groningen
    ClinicalTrials.gov Identifier:
    NCT02491151
    Other Study ID Numbers:
    • FLU-14O28
    First Posted:
    Jul 7, 2015
    Last Update Posted:
    May 3, 2017
    Last Verified:
    May 1, 2017
    Additional relevant MeSH terms:
    Candidiasis
    Candidiasis, Invasive

    Study Results

    No Results Posted as of May 3, 2017