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

Critical Illness Clinical Trial

— STAFE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154178
• Other study ID #: 2012_53
• Secondary ID: 2013 A00756 39
• Status: Completed
• Phase: N/A
• First received: May 24, 2014
• Last updated: March 22, 2017
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Fungal Infection
• Mycoses

Intervention

Other:
• Biomarker group
use of invasive fungal disease biomarkers (ß-1,3-glucan, mannan/anti-mannan antibodies)

Locations

Country	Name	City	State
France	ICU, Salengro Hospital, University Hospital of Lille	Lille	Nord

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	mortality in ICU	death during the 28 days following ICU admission	28 days after ICU admission
Secondary	duration of mechanical ventilation and ICU stay	mechanical ventilation duration during the 28 days following ICU admission	28 days after ICU admission
Secondary	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
Secondary	the cost of the antifungal therapy on a per duration prescribe		28 days after ICU admission
Secondary	the cost of hospital stays		28 days after ICU admission