Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients

NCT ID: NCT04252027

Last Updated: 2021-04-28

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

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-23

Study Completion Date

2020-03-05

Brief Summary

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This prospective study will research the exposure and its variability to fluconazole after longitudinal administration in critically ill patients

Detailed Description

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An open label, monocenter pharmacokinetic study will be carried out in critically ill patients, admitted at the University Hospitals Leuven, receiving multiple dose treatment with fluconazole.

The exposure to fluconazole in the ICU cohort over multiple days of treatment will be documented. Moreover, variability and the correlating covariates that can influence the fluconazole concentration, will be determined.

Conditions

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Critically Ill Patients

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Sample collection

Plasma and urine sample collection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \> 18 years
* Treatment with fluconazole
* Admitted to an ICU ward

Exclusion Criteria

* \< 18 years
* DNR 2 or 3
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabel Spriet, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S62242

Identifier Type: -

Identifier Source: org_study_id

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