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

University Hospital, Lille110 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Fungal Infection Critical Illness

Interventions

Biomarker groupOTHER

use of invasive fungal disease biomarkers (β-1,3-glucan, mannan/anti-mannan antibodies)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

ICU, Salengro Hospital, University Hospital of Lille

Lille, Nord, France

Outcomes

Primary Outcomes

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

Time frame: 7 days