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CompletedNCT02491151Updated May 3, 2017

Variability of Fluconazole Concentration in Critically Ill Patients

An observational study in Invasive Candidiasis, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-03.

Sponsored by University Medical Center Groningen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Invasive Candidiasis
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In context

Candidiasis

265 studies on the registry are indexed under Candidiasis; 20 are open to participants now.

This study's enrollment of 50 is below the median of 123 across 63 observational studies indexed under Candidiasis.

Browse Candidiasis studies →

Lead sponsor

University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients admitted to the University Medical Center Groningen who receive fluconazole

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

Exclusion Criteria:

  • Blood sampling not possible
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. Plasma concentrations of fluconazole in critically ill patients

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

    Time frame: Up to one month

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Study locations

1 site
  • University Medical Center Groningen
    Groningen, Netherlands
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References and documents

Publications

  • Boonstra JM, Martson AG, Sandaradura I, Kosterink JGW, van der Werf TS, Marriott DJE, Zijlstra JG, Touw DJ, Alffenaar JWC. Optimization of Fluconazole Dosing for the Prevention and Treatment of Invasive Candidiasis Based on the Pharmacokinetics of Fluconazole in Critically Ill Patients. Antimicrob Agents Chemother. 2021 Feb 17;65(3):e01554-20. doi: 10.1128/AAC.01554-20. Print 2021 Feb 17. PubMed 33361296 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02491151
Lead sponsor
University Medical Center Groningen
Responsible party
Jan-Willem C Alffenaar (Associate Professor of Medicine, University Medical Center Groningen) — Principal investigator
First posted
Jul 7, 2015
Start date
Oct 2014
Primary completion
Dec 2016
Completion
Dec 2016
Last update
May 3, 2017

Study contacts

Jan-WIllem Alffenaar, PharmD PhD
principal investigator · University Medical Center Groningen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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