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De-escalation - Antifungal Treatment Immunocompromised Patients (D-ATFIM)

U

University Hospital, Lille

Status

Completed

Conditions

Invasive Fungal Disease
Critical Illness

Study type

Observational

Funder types

Other

Identifiers

NCT03774316
2017_32
2017-A03113-50 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

275 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Saad Nseir, MD,PhD

Data sourced from clinicaltrials.gov

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