Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774316
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Invasive Fungal Disease Critical Illness

Detailed Description:
This is a 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated 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 : January 28, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

Inclusion Criteria:

  • Adults immunocompromised patients hospitalized in intensive care units
  • Predictable invasive mechanical ventilation duration > 48h
  • 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774316


Contacts
Layout table for location contacts
Contact: Saad Nseir, MD,PhD 03 20 44 44 95 ext +33 saad.nseir@chru-lille.fr

Locations
Layout table for location information
France
CHU Lille Recruiting
Lille, France, 59000
Contact: Saad Nseir, MD, PhD    33320444495    s-nseir@chru-lille.fr   
Contact: Damia MEDDOUR, CRA       damia.meddour@chru-lille.fr   
Sponsors and Collaborators
University Hospital, Lille
Investigators
Layout table for investigator information
Principal Investigator: Saad Nseir, MD,PhD University Hospital, Lille
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03774316    
Other Study ID Numbers: 2017_32
2017-A03113-50 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
De-escalation
Antifungal treatment
Mortality
Immunocompromised
Intensive care
Additional relevant MeSH terms:
Layout table for MeSH terms
Mycoses
Invasive Fungal Infections
Critical Illness
Disease Attributes
Pathologic Processes