Therapeutic Drug Monitoring of Antifungals in Intensive Care Units

Intensive Care Unit Patients Clinical Trial

— Fungi-up  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04502771
• Other study ID #: CRC_GHN_2020_003
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Unit Patients

Intervention

Drug:
• Antifungal treatment
Treatment by fluconazole, voriconazole,posaconazole or caspofungin during the patient stay in Intensive Care Unit

Locations

Country	Name	City	State
France	Hospices Civils de Lyon, Croix-Rousse Hospital	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antifungal blood concentration of patients admitted in intensive care units		Day 5 after antifungal initiation
Secondary	Adverse event	Impact of antifungal blood concentration on occurrence of adverse events and mycological failure	Day 30 after antifungal initiation