Critical Illness Clinical Trial
— STAFEOfficial title:
Fungal Biomarkers to Reduce Duration of Empirical Antifungal Therapy: a Randomized Comparative Study
Verified date | March 2017 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators hypothesized that the use of biomarkers of invasive fungal infections would increase the percentage of early discontinuation of empirical antifungal therapy and thus reduce the duration of treatment in ICU patients.
Status | Completed |
Enrollment | 110 |
Est. completion date | December 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age > or = 18 years - Patients requiring empiric antifungal therapy the first time in the ICU - Predictable duration of hospitalization in the ICU = 6 days Exclusion Criteria: - Neutropenia (WBC <1000 or neutrophils <500/mm3) - Immunosuppressive therapy (chemotherapy within 3 months prior to the ICU admission, solid organ graft under immunosuppressive therapy) - invasive fungal infection documented in the three previous months - Antifungal treatment in the three previous months - Pregnant or lactating women |
Country | Name | City | State |
---|---|---|---|
France | ICU, Salengro Hospital, University Hospital of Lille | Lille | Nord |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | percentage of early discontinuation of empiric antifungal therapy | Early discontinuation is defined as discontinuation of anti fungal treatment before the 7th day after the start of treatment | 7 days | |
Secondary | mortality in ICU | death during the 28 days following ICU admission | 28 days after ICU admission | |
Secondary | duration of mechanical ventilation and ICU stay | mechanical ventilation duration during the 28 days following ICU admission | 28 days after ICU admission | |
Secondary | fungal colonization / infection after antifungal therapy, with or without resistant strains | Any fungal colonization or infection diagnosed during the 28 days following ICU admission | 28 days after ICU admission | |
Secondary | the cost of the antifungal therapy on a per duration prescribe | 28 days after ICU admission | ||
Secondary | the cost of hospital stays | 28 days after ICU admission |
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