NCT02491151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

2.2 years

First QC Date

June 17, 2015

Last Update Submit

May 1, 2017

Conditions

Invasive Candidiasis

Outcome Measures

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

    Up to one month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patient is 18 years or older.
  • Treatment with fluconazole.
  • Written informed consent obtained from patient.
  • Written informed consent obtained from representative of patient.

You may not qualify if:

  • Blood sampling not possible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 33361296DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, serum

MeSH Terms

Conditions

Candidiasis, Invasive

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsInvasive Fungal Infections

Study Officials

  • Jan-WIllem Alffenaar, PharmD PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

June 17, 2015

First Posted

July 7, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

NL(1)