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

U

University Hospital, Lille

Status

Completed

Conditions

Fungal Infection
Critical Illness

Treatments

Other: Biomarker group

Study type

Interventional

Funder types

Other

Identifiers

NCT02154178
2013 A00756 39 (Other Identifier)
2012_53

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

110 participants in 2 patient groups

Biomarker group
Experimental group
Description:
Intervention group, in which the duration of empirical antifungal therapy will be based on the results of biomarkers. Biomarker group
Treatment:
Other: Biomarker group
Control group
No Intervention group
Description:
Control group, in which the duration of empirical antifungal therapy will be based on international recommendations (14 days).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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