Therapeutic Drug Monitoring of Antifungals in Intensive Care Units

NCT04502771 | Completed

• 1 other identifier: CRC_GHN_2020_003
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit Patients

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Antifungal blood concentration of patients admitted in intensive care units

  Day 5 after antifungal initiation

Secondary Outcomes (1)

• Adverse event

  Day 30 after antifungal initiation

Study Arms (1)

Antifungal treatment

Patients receiving antifungal treatment during their stay in Intensive Care Unit

Drug: Antifungal treatment

Interventions

Antifungal treatment DRUG

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

Antifungal treatment

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who received antifungals during their ICU stay and had a TDM

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon, Croix-Rousse Hospital

Lyon, 69004, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 6, 2020
• Study Start: January 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 7, 2020

Record last verified: 2020-08

Locations

FR (1)