De-escalation - Antifungal Treatment Immunocompromised Patients
D-ATFIM
De-escalation of Antifungal Treatment in Immunocompromised Critically Ill Patients With Suspected Invasive Candida Infection: Incidence, Associated Factors, and Safety
D-ATFIM
De-escalation of Antifungal Treatment in Immunocompromised Critically Ill Patients With Suspected Invasive Candida Infection: Incidence, Associated Factors, and Safety
Sponsor study identifier
Secondary identifiers
OTHER · ID-RCB number, ANSM
observational
275
1 country
1
Study Start
January 28, 2019
Actual (reported)Primary Completion
November 7, 2023
Actual (reported)Study Completion
November 7, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 7, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 3, 2018
Actual (reported)December 12, 2018
Actual (reported)January 28, 2019
Actual (reported)November 7, 2023
Actual (reported)November 7, 2023
Actual (reported)Percentage of patients with de-escalation of antifungal treatment
De-escalation is defined as a reduction in antifungal treatment spectrum (switch from echinocandines or Amphotericin B to Azoles) or stopping all antifungals within the 5 days following their initiation
5 days following start of antifungal treatment
Risk factors for de-escalation of antifungal therapy
during the 5 days following start of antifungal
Number of days free of mechanical ventilation
until day 28 after start of antifungal treatment
Number of days free of antifungal treatment
until day 28 after start of antifungal treatment
Length of ICU stay
until day 28 after start of antifungal treatment
All-cause mortality
until day 28 after start of antifungal treatment
Adults immunocompromised patients hospitalized in intensive care units (Age ≥18 years) Immunosuppression is defined by: * long-term immunosuppressive therapy (\> 3 months) or high-dose corticosteroid therapy (\> 0.5 mg / kg / day for at least 3 days) * Solid organ transplant * Solid cancer (active or in remission since \<5 years) * Malignant haemopathy * HIV infection with CD4 \<200
CHU Lille
Lille, 59000, France
Saad Nseir, MD,PhD
University Hospital, Lille
275 participants (actual enrollment reported by the registry).
First Submitted
December 3, 2018
First Posted
December 12, 2018
Study Start
January 28, 2019
Actual (reported)Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients
Contact the study team to confirm eligibility.
Primary Completion
November 7, 2023
Actual (reported)Study Completion
November 7, 2023
Actual (reported)Last Updated
December 23, 2025
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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