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CompletedNCT03774316D-ATFIMUpdated Dec 23, 2025

De-escalation - Antifungal Treatment Immunocompromised Patients

An observational study in Invasive Fungal Disease and Critical Illness, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
275
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed 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.

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Conditions studied

  • Invasive Fungal Disease
  • Critical Illness

Keywords

  • De-escalation
  • Antifungal treatment
  • Mortality
  • Immunocompromised
  • Intensive care
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In context

Invasive Fungal Infections

146 studies on the registry are indexed under Invasive Fungal Infections; 35 are open to participants now.

This study's enrollment of 275 is above the median of 120 across 68 observational studies indexed under Invasive Fungal Infections.

Browse Invasive Fungal Infections studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
275 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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

    Time frame: 5 days following start of antifungal treatment

Secondary outcomes

  1. Risk factors for de-escalation of antifungal therapy

    Clinical characteristics and conditions significantly associated with de-escalation by univariate analysis will be entered in a multiple regression model to determine those independently associated with de-escalation

    Time frame: during the 5 days following start of antifungal

  2. Number of days free of mechanical ventilation

    days with no mechanical ventilation

    Time frame: until day 28 after start of antifungal treatment

  3. Number of days free of antifungal treatment

    days with no antifungal treatment

    Time frame: until day 28 after start of antifungal treatment

  4. Length of ICU stay

    days in the ICU

    Time frame: until day 28 after start of antifungal treatment

  5. All-cause mortality

    mortality related to any cause

    Time frame: until day 28 after start of antifungal treatment

  6. Percentage of patients with reoccurrence of candidiasis

    reccurrence of candidiasis is defined as a new episode after the end of antifungal treatment

    Time frame: until day 7 after stop of antifungal treatment

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Study locations

1 site
  • CHU Lille
    Lille, 59000, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03774316
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Dec 12, 2018
Start date
Jan 28, 2019
Primary completion
Nov 7, 2023
Completion
Nov 7, 2023
Last update
Dec 23, 2025

Study contacts

Saad Nseir, MD,PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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