NCT04252027

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 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

April 23, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2020

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

January 28, 2020

Last Update Submit

April 26, 2021

Conditions

Critically Ill Patients

Keywords

PharmacokineticsFluconazoleVariabilityTarget attainment

Outcome Measures

Primary Outcomes (2)

  • Exposure to fluconazole (trough levels)

    To document the trough levels (Cmin) of fluconazole in an ICU cohort over multiple days of treatment

    On the day of sampling

  • Exposure to fluconazole (trough levels)

    Determine if the Cmin target levels are attained.

    June 2020

Secondary Outcomes (2)

  • Variability in fluconazole trough levels

    June 2020

  • Influencing covariates

    June 2020

Interventions

Sample collectionOTHER

Plasma and urine sample collection

Eligibility Criteria

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

Critically ill patients.

You may qualify if:

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

You may not qualify if:

  • \< 18 years
  • DNR 2 or 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Isabel Spriet, PharmD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2020

First Posted

February 5, 2020

Study Start

April 23, 2019

Primary Completion

March 5, 2020

Study Completion

March 5, 2020

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

BE(1)