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Therapeutic Drug Monitoring of Antifungals in Intensive Care Units

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04502771
Acronym
Fungi-up
Enrollment
200
Registered
2020-08-06
Start date
2018-01-01
Completion date
2019-12-31
Last updated
2020-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit Patients

Keywords

Fluconazole, Voriconazole, Posaconazole, Caspofungin, Therapeutic drug monitoring, Blood concentration, Under-dosing, Over-dosing, Intensive Care Unit

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.

Interventions

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Antifungal blood concentration of patients admitted in intensive care unitsDay 5 after antifungal initiation

Secondary

MeasureTime frameDescription
Adverse eventDay 30 after antifungal initiationImpact of antifungal blood concentration on occurrence of adverse events and mycological failure

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026