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

Primary Purpose

Fungal Infection, Critical Illness

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biomarker group
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fungal Infection focused on measuring empiric antifungal therapy, biomarkers, invasive fungal infection, Candida

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • ICU, Salengro Hospital, University Hospital of Lille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Biomarker group

Control group

Arm Description

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

Control group, in which the duration of empirical antifungal therapy will be based on international recommendations (14 days).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

mortality in ICU
death during the 28 days following ICU admission
duration of mechanical ventilation and ICU stay
mechanical ventilation duration during the 28 days following 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
the cost of the antifungal therapy on a per duration prescribe
the cost of hospital stays

Full Information

First Posted
May 24, 2014
Last Updated
March 22, 2017
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT02154178
Brief Title
Fungal Biomarkers to Reduce Duration of Empirical Antifungal Therapy: a Randomized Comparative Study (STAFE)
Acronym
STAFE
Official Title
Fungal Biomarkers to Reduce Duration of Empirical Antifungal Therapy: a Randomized Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fungal Infection, Critical Illness
Keywords
empiric antifungal therapy, biomarkers, invasive fungal infection, Candida

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biomarker group
Arm Type
Experimental
Arm Description
Intervention group, in which the duration of empirical antifungal therapy will be based on the results of biomarkers. Biomarker group
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group, in which the duration of empirical antifungal therapy will be based on international recommendations (14 days).
Intervention Type
Other
Intervention Name(s)
Biomarker group
Other Intervention Name(s)
intervention group
Intervention Description
use of invasive fungal disease biomarkers (β-1,3-glucan, mannan/anti-mannan antibodies)
Primary Outcome Measure Information:
Title
percentage of early discontinuation of empiric antifungal therapy
Description
Early discontinuation is defined as discontinuation of anti fungal treatment before the 7th day after the start of treatment
Time Frame
7 days
Secondary Outcome Measure Information:
Title
mortality in ICU
Description
death during the 28 days following ICU admission
Time Frame
28 days after ICU admission
Title
duration of mechanical ventilation and ICU stay
Description
mechanical ventilation duration during the 28 days following ICU admission
Time Frame
28 days after ICU admission
Title
fungal colonization / infection after antifungal therapy, with or without resistant strains
Description
Any fungal colonization or infection diagnosed during the 28 days following ICU admission
Time Frame
28 days after ICU admission
Title
the cost of the antifungal therapy on a per duration prescribe
Time Frame
28 days after ICU admission
Title
the cost of hospital stays
Time Frame
28 days after ICU admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saad Nseir, MD, PhD
Organizational Affiliation
Univ Hosp of Lille, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICU, Salengro Hospital, University Hospital of Lille
City
Lille
State/Province
Nord
ZIP/Postal Code
59035
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28936678
Citation
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.
Results Reference
derived

Learn more about this trial

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

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