Fungal InfectionSTAFENCT02154178
Fungal Biomarkers to Reduce Duration of Empirical Antifungal Therapy: a Randomized Comparative Study (STAFE)
A study testing Biomarker group in people with Fungal Infection and Critical Illness, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fungal Infection, Critical Illness
- What is being tested?
- Biomarker group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > or = 18 years
- Patients requiring empiric antifungal therapy the first time in the ICU
- Predictable duration of hospitalization in the ICU ≥ 6 days
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
ICU, Salengro Hospital, University Hospital of Lille
Lille, Nord, 59035
About this study
Official title: Fungal Biomarkers to Reduce Duration of Empirical Antifungal Therapy: a Randomized Comparative Study
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.
Read the 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.
- Conditions
- Fungal Infection, Critical Illness
- Being tested
- Biomarker group
- Keywords
- empiric antifungal therapy, biomarkers, invasive fungal infection, Candida
- Medical subject headings
- Mycoses, Critical Illness, Invasive Fungal Infections, Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker groupOther
Also called intervention group
use of invasive fungal disease biomarkers (β-1,3-glucan, mannan/anti-mannan antibodies)
| Study group | Role | What they receive |
|---|---|---|
| Biomarker group | Experimental | Intervention group, in which the duration of empirical antifungal therapy will be based on the results of biomarkers.
Biomarker group Receives: Other: Biomarker group |
| Control group | No intervention | Control group, in which the duration of empirical antifungal therapy will be based on international recommendations (14 days). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (5)
mortality in ICU
death during the 28 days following ICU admission
Measured: 28 days after ICU admission
duration of mechanical ventilation and ICU stay
mechanical ventilation duration during the 28 days following ICU admission
Measured: 28 days after 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
Measured: 28 days after ICU admission
the cost of the antifungal therapy on a per duration prescribe
Measured: 28 days after ICU admission
the cost of hospital stays
Measured: 28 days after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fungal InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saad Nseir, MD, PhD, Principal investigator, Univ Hosp of Lille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154178
- Sponsor's protocol ID
- 2012_53
- Other IDs
- 2013 A00756 39
- Acronym
- STAFE
- Status last verified
- Mar 2017
- First submitted
- 24 May 2014
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28936678
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fungal Biomarkers to Reduce Duration of Empirical Antifungal Therapy: a Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT02154178
- Acronym / sponsor ID
- STAFE / 2012_53
- Conditions
- Fungal Infection, Critical Illness
- Keywords
- empiric antifungal therapy, biomarkers, invasive fungal infection, Candida
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biomarker group | Experimental | Other: Biomarker groupIntervention group, in which the duration of empirical antifungal therapy will be based on the results of biomarkers. Biomarker group |
| Control group | No intervention | –Control group, in which the duration of empirical antifungal therapy will be based on international recommendations (14 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > or = 18 years
- Patients requiring empiric antifungal therapy the first time in the ICU
- Predictable duration of hospitalization in the ICU ≥ 6 days
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker groupAlso: intervention groupuse of invasive fungal disease biomarkers (β-1,3-glucan, mannan/anti-mannan antibodies) | Other | Biomarker group |
Primary outcome
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
5 secondary outcomes
mortality in ICU
Time frame: 28 days after ICU admission
duration of mechanical ventilation and ICU stay
Time frame: 28 days after ICU admission
fungal colonization / infection after antifungal therapy, with or without resistant strains
Time frame: 28 days after ICU admission
the cost of the antifungal therapy on a per duration prescribe
Time frame: 28 days after ICU admission
the cost of hospital stays
Time frame: 28 days after ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 28936678Rouze 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saad Nseir, MD, PhD principal investigator
Univ Hosp of Lille, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomarker group in people with Fungal Infection and Critical Illness, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of early discontinuation of empiric antifungal therapy (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02154178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.