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NCT Number: NCT02154178

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

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.

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Key information

Conditions

Fungal Infection Bacterial Infections and Mycoses Critical Illness Disease Attributes Infections Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Torulopsis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICU, Salengro Hospital, University Hospital of Lille

Lille, Nord, 59035, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biomarker group

Other

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

Other names: intervention group

Primary outcomes

  1. 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

  1. mortality in ICU

    Time frame: 28 days after ICU admission

    death during the 28 days following ICU admission

  2. duration of mechanical ventilation and ICU stay

    Time frame: 28 days after ICU admission

    mechanical ventilation duration during the 28 days following ICU admission

  3. fungal colonization / infection after antifungal therapy, with or without resistant strains

    Time frame: 28 days after ICU admission

    Any fungal colonization or infection diagnosed during the 28 days following ICU admission

  4. the cost of the antifungal therapy on a per duration prescribe

    Time frame: 28 days after ICU admission

  5. the cost of hospital stays

    Time frame: 28 days after ICU admission

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: STAFE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 3, 2014
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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