Therapeutic Drug Monitoring of Antifungals in Intensive Care Units

NCT ID: NCT04502771

Last Updated: 2020-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-12-31

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.

Detailed Description

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Conditions

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Intensive Care Unit Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Antifungal treatment

Patients receiving antifungal treatment during their stay in Intensive Care Unit

Antifungal treatment

Intervention Type DRUG

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

Interventions

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Antifungal treatment

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

Intervention Type DRUG

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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospices Civils de Lyon, Croix-Rousse Hospital

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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CRC_GHN_2020_003

Identifier Type: -

Identifier Source: org_study_id

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