Variability of Fluconazole Concentration in Critically Ill Patients

NCT ID: NCT02491151

Last Updated: 2017-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Invasive Candidiasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Jan-Willem C Alffenaar

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan-WIllem Alffenaar, PharmD PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 33361296 (View on PubMed)

Other Identifiers

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FLU-14O28

Identifier Type: -

Identifier Source: org_study_id

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