D-ATFIM: De-escalation - Antifungal Treatment Immunocompromised Patients

Sponsor
University Hospital, Lille (Other)
Overall Status
Recruiting
CT.gov ID
NCT03774316
Collaborator
(none)
296
1
43.1
6.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    296 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    De-escalation of Antifungal Treatment in Immunocompromised Critically Ill Patients With Suspected Invasive Candida Infection: Incidence, Associated Factors, and Safety
    Actual Study Start Date :
    Jan 28, 2019
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of patients with de-escalation of antifungal treatment [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 Outcome Measures

    1. Risk factors for de-escalation of antifungal therapy [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 [until day 28 after start of antifungal treatment]

      days with no mechanical ventilation

    3. Number of days free of antifungal treatment [until day 28 after start of antifungal treatment]

      days with no antifungal treatment

    4. Length of ICU stay [until day 28 after start of antifungal treatment]

      days in the ICU

    5. All-cause mortality [until day 28 after start of antifungal treatment]

      mortality related to any cause

    6. Percentage of patients with reoccurrence of candidiasis [until day 7 after stop of antifungal treatment]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Lille Lille France 59000

    Sponsors and Collaborators

    • University Hospital, Lille

    Investigators

    • Principal Investigator: Saad Nseir, MD,PhD, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT03774316
    Other Study ID Numbers:
    • 2017_32
    • 2017-A03113-50
    First Posted:
    Dec 12, 2018
    Last Update Posted:
    Apr 23, 2021
    Last Verified:
    Jun 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Lille
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 23, 2021