Therapeutic Drug Monitoring of Antifungals in Intensive Care Units

Study Overview
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Brief Summary
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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.

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

Conditions
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Intensive Care Unit Patients

Intervention / Treatment
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* Drug: Antifungal treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients who received antifungals including fluconazole, voriconazole, posaconazole, or caspofungin, during their ICU stay and had a Therapeutic Drug Monitoring (TDM) Exclusion Criteria: Patients without antifungal treatment Patients who received an antifungal combination Pediatric patients Patients who were not admitted in ICU Patients who did not have a TDM

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Antifungal treatment<br>Patients receiving antifungal treatment during their stay in Intensive Care Unit | Drug: Antifungal treatment<br>* Treatment by fluconazole, voriconazole,posaconazole or caspofungin during the patient stay in Intensive Care Unit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antifungal blood concentration of patients admitted in intensive care units |  | Day 5 after antifungal initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event | Impact of antifungal blood concentration on occurrence of adverse events and mycological failure | Day 30 after antifungal initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluconazole, Voriconazole, Posaconazole, Caspofungin, Therapeutic drug monitoring, Blood concentration, Under-dosing, Over-dosing, Intensive Care Unit