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

Not Applicable

Completed

• Conditions: Critical Illness; Fungal Infection
• Interventions: Other: Biomarker group

• Registration Number: NCT02154178
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Study First Submitted: 2014-05-24
• Study First Submitted QC: 2014-05-29
• Study First Posted: 2014-06-03
• Study Start: 2014-07
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biomarker group	Biomarker group	Intervention group, in which the duration of empirical antifungal therapy will be based on the results of biomarkers. Biomarker group

Primary Outcome Measures

Name	Time	Method
percentage of early discontinuation of empiric antifungal therapy	7 days	Early discontinuation is defined as discontinuation of anti fungal treatment before the 7th day after the start of treatment

Secondary Outcome Measures

Name	Time	Method
mortality in ICU	28 days after ICU admission	death during the 28 days following 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	mechanical ventilation duration during the 28 days following ICU admission
fungal colonization / infection after antifungal therapy, with or without resistant strains	28 days after ICU admission	Any fungal colonization or infection diagnosed during the 28 days following ICU admission

Trial Locations

Locations (1)

ICU, Salengro Hospital, University Hospital of Lille; 🇫🇷 Lille, Nord, France