Fungal Biomarkers to Reduce Duration of Empirical Antifungal Therapy: a Randomized Comparative Study
Overview
- Phase
- Not Applicable
- Intervention
- Biomarker group
- Conditions
- Fungal Infection
- Sponsor
- University Hospital, Lille
- Enrollment
- 110
- Locations
- 2
- Primary Endpoint
- percentage of early discontinuation of empiric antifungal therapy
- Status
- Completed
- Last Updated
- 10 days ago
Overview
Brief Summary
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.
Detailed Description
The duration of empirical/preemptive anti fungal treatment will be based in the intervention group on biomarker results. Biomarkers of fungal disease will performed before starting anti fungal treatment and at day 4.
Investigators
Eligibility Criteria
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
Arms & Interventions
Biomarker group
Intervention group, in which the duration of empirical antifungal therapy will be based on the results of biomarkers. Biomarker group
Intervention: Biomarker group
Control group
Control group, in which the duration of empirical antifungal therapy will be based on international recommendations (14 days).
Outcomes
Primary Outcomes
percentage of early discontinuation of empiric antifungal therapy
Time Frame: 7 days
Early discontinuation is defined as discontinuation of anti fungal treatment before the 7th day after the start of treatment
Secondary Outcomes
- mortality in ICU(28 days after ICU admission)
- the cost of the antifungal therapy on a per duration prescribe(28 days after ICU admission)
- the cost of hospital stays(28 days after ICU admission)
- duration of mechanical ventilation and ICU stay(28 days after ICU admission)
- fungal colonization / infection after antifungal therapy, with or without resistant strains(28 days after ICU admission)