Fungal Biomarkers to Reduce Duration of Empirical Antifungal Therapy: a Randomized Comparative Study (STAFE)

Study 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.

Official Title
-----------------
Fungal Biomarkers to Reduce Duration of Empirical Antifungal Therapy: a Randomized Comparative Study

Conditions
-----------------
Fungal Infection, Critical Illness

Intervention / Treatment
-----------------
* Other: Biomarker group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biomarker group<br>Intervention group, in which the duration of empirical antifungal therapy will be based on the results of biomarkers. Biomarker group | Other: Biomarker group<br>* use of invasive fungal disease biomarkers (β-1,3-glucan, mannan/anti-mannan antibodies)<br>* Other names: intervention group;|
| No Intervention: Control group<br>Control group, in which the duration of empirical antifungal therapy will be based on international recommendations (14 days). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality in ICU | death during the 28 days following ICU admission | 28 days after ICU admission | 
| duration of mechanical ventilation and ICU stay | mechanical ventilation duration during the 28 days following ICU admission | 28 days after ICU admission | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
empiric antifungal therapy, biomarkers, invasive fungal infection, Candida