D-ATFIM: De-escalation - Antifungal Treatment Immunocompromised Patients
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 |
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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
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Number of days free of mechanical ventilation [until day 28 after start of antifungal treatment]
days with no mechanical ventilation
- Number of days free of antifungal treatment [until day 28 after start of antifungal treatment]
days with no antifungal treatment
- Length of ICU stay [until day 28 after start of antifungal treatment]
days in the ICU
- All-cause mortality [until day 28 after start of antifungal treatment]
mortality related to any cause
- 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
Inclusion Criteria:
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Adults immunocompromised patients hospitalized in intensive care units
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Predictable invasive mechanical ventilation duration > 96h
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Signed consent (by patient or its representative)
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First antifungal treatment initiation in ICU for proven or suspected candida infection
Exclusion Criteria:
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Pregnant or breast-feeding women.
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Fungal infection other than invasive candida
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Prophylactic antifungal treatment.
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Lack of informed consent
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Predictable mechanical ventilation duration less than 48 hours
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Patients discharged from ICU before the 5th day after initiation of TAF
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- 2017_32
- 2017-A03113-50