Therapeutic Drug Monitoring of Antifungals in Intensive Care Units

Completed

• Conditions: Intensive Care Unit Patients
• Interventions: Drug: Antifungal treatment

• Registration Number: NCT04502771
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-08
• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-06
• Last Update Submitted: 2020-08-06
• Last Update Posted: 2020-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Antifungal treatment	Antifungal treatment	Patients receiving antifungal treatment during their stay in Intensive Care Unit

Primary Outcome Measures

Name	Time	Method
Antifungal blood concentration of patients admitted in intensive care units	Day 5 after antifungal initiation

Secondary Outcome Measures

Name	Time	Method
Adverse event	Day 30 after antifungal initiation	Impact of antifungal blood concentration on occurrence of adverse events and mycological failure

Trial Locations

Locations (1)

Hospices Civils de Lyon, Croix-Rousse Hospital; 🇫🇷 Lyon, France