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
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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 |
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Invasive Fungal Disease Critical Illness |
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 |
- 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
- 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

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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 |
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 > 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

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
Contact: Saad Nseir, MD,PhD | 03 20 44 44 95 ext +33 | saad.nseir@chru-lille.fr |
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 |
Principal Investigator: | Saad Nseir, MD,PhD | University Hospital, Lille |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
De-escalation Antifungal treatment Mortality Immunocompromised Intensive care |
Mycoses Invasive Fungal Infections Critical Illness Disease Attributes Pathologic Processes |