De-escalation - Antifungal Treatment Immunocompromised Patients

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

275 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-28

Study Completion Date

2023-11-07

Brief Summary

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A small proportion of intensive care unit patients receiving antifungals have a proven invasive fungal infection. However, antifungal treatment has side effects such as toxicity, emergence of resistance, and high cost. Moreover, empirical antifungal treatment is still a matter for debate in these patients. Our study aimed to determine the incidence, associated factors, and safety of de-escalation of antifungals in immunocompromised critically ill patients.

This prospective observational study is conducted in 14 ICU, during a 6 months period. All immunocompromised patients hospitalized for \>5d and treated with antifungals for suspected or proven invasive candida infection will be included De-escalation is defined as a reduction in antifungal spectrum or stopping initial drugs within the 5 days following their initiation. The three antifungals considered in this study are from the narrowest to the widest spectrum: fluconazole, caspofungin and liposomal amphotericin B.

Detailed Description

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This is a retrospective and prospective observational multicenter study, aiming to determine the incidence, and safety of antifungal de-escalation in immunocompromised patients, and also factors associated with de-escalation.

Conditions

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Invasive Fungal Disease Critical Illness

Keywords

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De-escalation Antifungal treatment Mortality Immunocompromised Intensive care

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adults immunocompromised patients hospitalized in intensive care units
* Predictable invasive mechanical ventilation duration \> 96h
* Signed consent (by patient or its representative)
* First antifungal treatment initiation in ICU for proven or suspected candida infection

Exclusion Criteria

* Pregnant or breast-feeding women.
* Fungal infection other than invasive candida
* Prophylactic antifungal treatment.
* Lack of informed consent
* Predictable mechanical ventilation duration less than 48 hours
* Patients discharged from ICU before the 5th day after initiation of TAF

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saad Nseir, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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CHU Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2017-A03113-50

Identifier Type: OTHER

Identifier Source: secondary_id

2017_32

Identifier Type: -

Identifier Source: org_study_id