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

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Fungal Infection
• Intervention / Treatment: Other: Biomarker group

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nord
    • Lille, Nord, France, 59035
      • ICU, Salengro Hospital, University Hospital of Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Saad Nseir, MD, PhD, Univ Hosp of Lille, France

Publications and helpful links

General Publications

• Rouze A, Loridant S, Poissy J, Dervaux B, Sendid B, Cornu M, Nseir S; S-TAFE study group. Biomarker-based strategy for early discontinuation of empirical antifungal treatment in critically ill patients: a randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1668-1677. doi: 10.1007/s00134-017-4932-8. Epub 2017 Sep 22.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 24, 2014
• First Submitted That Met QC Criteria: May 29, 2014
• First Posted (Estimated): June 3, 2014

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: biomarkers; Candida; invasive fungal infection; empiric antifungal therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Bacterial Infections and Mycoses; Pathological Conditions, Signs and Symptoms; Invasive Fungal Infections; Critical Illness; Mycoses; Torulopsis
• Other Study ID Numbers: 2012_53; 2013 A00756 39 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO