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Completed

NCT Number: NCT03774316

De-escalation - Antifungal Treatment Immunocompromised Patients

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.

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Key information

Conditions

Invasive Fungal Disease Bacterial Infections and Mycoses Critical Illness Disease Attributes Infections Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Lille

Lille, 59000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of patients with de-escalation of antifungal treatment

    Time frame: 5 days following start 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

Secondary outcomes

  1. Risk factors for de-escalation of antifungal therapy

    Time frame: during the 5 days following start of antifungal

    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

  2. Number of days free of mechanical ventilation

    Time frame: until day 28 after start of antifungal treatment

    days with no mechanical ventilation

  3. Number of days free of antifungal treatment

    Time frame: until day 28 after start of antifungal treatment

    days with no antifungal treatment

  4. Length of ICU stay

    Time frame: until day 28 after start of antifungal treatment

    days in the ICU

  5. All-cause mortality

    Time frame: until day 28 after start of antifungal treatment

    mortality related to any cause

  6. Percentage of patients with reoccurrence of candidiasis

    Time frame: until day 7 after stop of antifungal treatment

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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

De-escalation of Antifungal Treatment in Immunocompromised Critically Ill Patients With Suspected Invasive Candida Infection: Incidence, Associated Factors, and Safety

Acronym: D-ATFIM

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 12, 2018
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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