Fungal Biomarkers to Reduce Duration of Empirical Antifungal Therapy: a Randomized Comparative Study (STAFE)
NCT ID: NCT02154178
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
110 participants
INTERVENTIONAL
2014-07-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Biomarkers of fungal disease will performed before starting anti fungal treatment and at day 4.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Biomarker group
Intervention group, in which the duration of empirical antifungal therapy will be based on the results of biomarkers.
Biomarker group
Biomarker group
use of invasive fungal disease biomarkers (β-1,3-glucan, mannan/anti-mannan antibodies)
Control group
Control group, in which the duration of empirical antifungal therapy will be based on international recommendations (14 days).
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Biomarker group
use of invasive fungal disease biomarkers (β-1,3-glucan, mannan/anti-mannan antibodies)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients requiring empiric antifungal therapy the first time in the ICU
* Predictable duration of hospitalization in the ICU ≥ 6 days
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Lille
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Saad Nseir, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Univ Hosp of Lille, France
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ICU, Salengro Hospital, University Hospital of Lille
Lille, Nord, France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013 A00756 39
Identifier Type: OTHER
Identifier Source: secondary_id
2012_53
Identifier Type: -
Identifier Source: org_study_id