Fungi-up: Therapeutic Drug Monitoring of Antifungals in Intensive Care Units

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT04502771

Collaborator

(none)

200

Enrollment

Location

Actual Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Antifungals under- and over-dosing are frequently deplored in patients treated with antifungals and receiving recommended doses, mostly in critically-ill patients. This situation is well-described for antifungals from the azoles class mostly in patients with liver dysfunction or having concomitant drugs that may interact with azoles. This situation is less-described using echinocandins, although recent studies reported caspofungin underdosing for critically-ill patients. Considering that antifungals under-dosing was demonstrated to be associated with an increase in mortality, it is of utmost importance to analyse the relevance of therapeutic drug monitoring (TDM) for patients admitted in intensive care units (ICU). This will help to identify which patients are the more prone to antifungal under or over-dosing. Indeed, antifungals under-dosing may favour the development of clinical resistance to antifungals and increase mortality, whereas over-dosing may result in adverse events that may lead to treatment discontinuation.

Condition or Disease	Intervention/Treatment	Phase
Intensive Care Unit Patients	Drug: Antifungal treatment

Study Design

Study Type:

Observational

Actual Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Therapeutic Drug Monitoring of Antifungals in Patients From Intensive Care Units: a Retrospective Study

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Antifungal treatment Patients receiving antifungal treatment during their stay in Intensive Care Unit	Drug: Antifungal treatment Treatment by fluconazole, voriconazole,posaconazole or caspofungin during the patient stay in Intensive Care Unit

Arm

Intervention/Treatment

Antifungal treatment

Patients receiving antifungal treatment during their stay in Intensive Care Unit

Drug: Antifungal treatment

Treatment by fluconazole, voriconazole,posaconazole or caspofungin during the patient stay in Intensive Care Unit

Outcome Measures

Primary Outcome Measures

Antifungal blood concentration of patients admitted in intensive care units [Day 5 after antifungal initiation]

Secondary Outcome Measures

Adverse event [Day 30 after antifungal initiation]
Impact of antifungal blood concentration on occurrence of adverse events and mycological failure

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients who received antifungals including fluconazole, voriconazole, posaconazole, or caspofungin, during their ICU stay and had a Therapeutic Drug Monitoring (TDM)