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

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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

Tracking Information
First Submitted Date December 3, 2018
First Posted Date December 12, 2018
Last Update Posted Date June 30, 2020
Actual Study Start Date January 28, 2019
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 11, 2018)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 13, 2018)
  • 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
  • Number of days free of mechanical ventilation [ Time Frame: until day 28 after start of antifungal treatment ]
    days with no mechanical ventilation
  • Number of days free of antifungal treatment [ Time Frame: until day 28 after start of antifungal treatment ]
    days with no antifungal treatment
  • Length of ICU stay [ Time Frame: until day 28 after start of antifungal treatment ]
    days in the ICU
  • All-cause mortality [ Time Frame: until day 28 after start of antifungal treatment ]
    mortality related to any cause
  • 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
Original Secondary Outcome Measures
 (submitted: December 11, 2018)
  • factors independently associated with de-escalation of antifungal therapy [ Time Frame: during the 5 days following start of antifungal ]
    Clinical characteristics and conditions significantly associated with de-escalation will be entered in a multiple regression model to determine thos independently associated with de-escalation
  • Number of days free of mechanical ventilation [ Time Frame: until day 28 after start of antifungal treatment ]
    days with no mechanical ventilation
  • Number of days free of antifungal treatment [ Time Frame: until day 28 after start of antifungal treatment ]
    days with no antifungal treatment
  • Length of ICU stay [ Time Frame: until day 28 after start of antifungal treatment ]
    days in the ICU
  • All-cause mortality [ Time Frame: until day 28 after start of antifungal treatment ]
    mortality related to any cause
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title De-escalation - Antifungal Treatment Immunocompromised Patients
Official Title De-escalation of Antifungal Treatment in Immunocompromised Critically Ill Patients With Suspected Invasive Candida Infection: Incidence, Associated Factors, and Safety
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Invasive Fungal Disease
  • Critical Illness
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 11, 2018)
296
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Saad Nseir, MD,PhD 03 20 44 44 95 ext +33 saad.nseir@chru-lille.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03774316
Other Study ID Numbers 2017_32
2017-A03113-50 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators Not Provided
Investigators
Principal Investigator: Saad Nseir, MD,PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date June 2020