Invasive CandidiasisSEATNCT03538912
Early Discontinuation of Empirical Antifungal Therapy and Biomarkers
A study testing Biomarker strategy and Routine strategy in people with Invasive Candidiasis, run by University Hospital, Lille at 10 sites in France.
Trial summary
Empirical antifungal therapy (EAT) is frequently prescribed to septic critically ill patients with risk factors for invasive Candida infections (ICI). However, among patients without subsequent proven ICI, antifungal discontinuation is rarely performed, resulting in unnecessary antifungal overuse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Candidiasis
- What is being tested?
- Biomarker strategy and Routine strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 10 sitesFrance
- Study dates
- 6 Jun 2018to 3 Sep 2024
- 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
- Patient older than 18 years
- Who require EAT for the first time in the ICU (this treatment is prescribed based on the presence of risk factors and clinical suspicion of ICI)
- With an expected ICU length of stay of at least 6 days after EAT initiation
- Informed written consent
Who cannot join
- Neutropenia (neutrophil count <500 cells /µL)
- Active malignant hemopathy
- Bone marrow transplantation in the last 6 months
- Polyvalent immunoglobulins in the past months
- Documented ICI in the past 3 months
- Pregnancy or breastfeeding
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CH ARRAS
Arras
CH de DOUAI
Douai
CH Dunkerque
Dunkirk
Centre Hospitalier Dr Schaffner
Lens
Ch Dr.Schaffner de Lens
Lens
Hôpital Roger Salengro, CHU
Lille
CH Roubaix
Roubaix
CHU de Rouen
Rouen
Ch Tourcoing
Tourcoing
Centre hospitalier de valenciennes
Valenciennes
About this study
Official title: Impact of the Use of Biomarkers on Early Discontinuation of Empirical Antifungal Therapy in Critically Ill Patients: a Randomized Controlled Study.
Empirical antifungal therapy (EAT) is frequently prescribed to septic critically ill patients with risk factors for invasive Candida infections (ICI). However, among patients without subsequent proven ICI, antifungal discontinuation is rarely performed, resulting in unnecessary antifungal overuse.
The investigators postulate that the use of fungal biomarkers could increase the percentage of early discontinuation of EAT among critically ill patients suspected of ICI, as compared with a standard strategy, without negative impact on day 28-mortality.
To test this hypothesis, the investigators designed a randomized controlled open-label parallel-group study.
Read the detailed description
Patients requiring EAT will be randomly assigned to:
- intervention group: a strategy in which EAT duration is determined by (1,3)-B-Dglucan and mannan serum assays, performed on day 0 (day of EAT initiation) and day 3. Early stop recommendation, provided before day 7, will be determined using an algorithm based on the results of biomarkers.
- control group: a routine care strategy, based on international guidelines, which recommend 14 days of treatment for patients without subsequent proven ICI, and who improve under antifungal treatment, or less in other situations.
- Conditions
- Invasive Candidiasis
- Being tested
- Biomarker strategy, Routine strategy
- Keywords
- empirical antifungal therapy, invasive candidiasis, biomarkers, de-escalation, ICU
- Medical subject headings
- Candidiasis, Invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker strategyOther
EAT duration is determined by β-D-1,3-glucan and mannan serum assays, performed at day 0 (day of EAT initiation) and day 3.
Routine strategyOther
EAT duration is based on IDSA guidelines, which recommend 14 days of treatment for patients without subsequent proven ICI, and who improve under antifungal treatment, or less in other situations.
| Study group | Role | What they receive |
|---|---|---|
| Biomarker group | Other | patient follow the Biomarker strategy Receives: Other: Biomarker strategy |
| Routine group | Other | patient follow the routine strategy Receives: Other: Routine strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients receiving early discontinuation of EAT, defined as a discontinuation strictly before day 7 after EAT initiation
This trial is designed to demonstrate whether, in critically ill patients suspected for ICI, the biomarker strategy, as compared with a standard strategy, is at the same time:
- superior in terms of antifungal use and
- Non-inferior in terms of death
Measured: day 7 after EAT initiation
Secondary outcomes (13)
death from any cause
This trial is designed to demonstrate whether, in critically ill patients suspected for ICI, the biomarker strategy, as compared with a standard strategy, is at the same time:
- superior in terms of antifungal use and
- Non-inferior in terms of death
Measured: day 28 after EAT initiation
percentage of patients who presented a proven ICI after EAT discontinuation
Measured: at day 28 or ICU discharge, if it occurs before day 28
percentage of patients who received at least two periods of antifungal treatment (prescribed for separate episodes of suspected or proven ICI)
Measured: at day 28 or ICU discharge, if it occurs before day 28
intensity of Candida colonization during ICU stay
Five body sites (among urine, anal swabs, pharyngeal swabs, nasal swabs, axillary swabs, gastric aspirates if patients have a nasogastric tube, and tracheal aspirates if patients are intubated or have a tracheotomy) are sampled on day 0 and then once per week for the semi-quantitative determination of yeast colonisation. The number of colony-forming units is scored as follows: score 1, <10 colony-forming units; score 2, 10 to 50 colony-forming units; score 3, >50 colony-forming units; score 4, >50 colony-forming units confluent. Intensity of colonization is determined for each date of sampling, by dividing the sum score for each colonized site by the number of sites sampled giving a mean Candida load. An overall score of >4 is possible in the case of isolation of several Candida species.
Measured: at day 28 or ICU discharge, if it occurs before day 28
percentage of patients colonized with a resistant strain of Candida
Measured: at day 28 or ICU discharge, if it occurs before day 28
antifungal-free days
Measured: at day 28 or ICU discharge, if it occurs before day 28
ventilator-free days
Measured: at day 28 or ICU discharge, if it occurs before day 28
ICU-free days
Measured: at day 28 or ICU discharge, if it occurs before day 28
ICU mortality
Measured: at day 28 or ICU discharge, if it occurs before day 28
day 90 mortality
Measured: at day 90
Characterization of the fungal intestinal microbiota studied by standard mycology
Measured: at baseline, at Day 7, day 14 day 21 and day 28
Characterization of the fungal intestinal microbiota studied by metagenomics
Measured: at baseline, at Day 7, day 14 day 21 and day 28
Characterization of the bacterial intestinal microbiota studied by culture bacteriology
Measured: at baseline, at Day 7, day 14 day 21 and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start6 Jun 2018
- Primary completion3 Sep 2024
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive CandidiasisStudies 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
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anahita Rouze, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538912
- Sponsor's protocol ID
- 2017_07
- Other IDs
- 2017-003793-13, 2017
- Acronym
- SEAT
- Status last verified
- May 2026
- First submitted
- 25 Apr 2018
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Use of Biomarkers on Early Discontinuation of Empirical Antifungal Therapy in Critically Ill Patients: a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT03538912
- Acronym / sponsor ID
- SEAT / 2017_07
- Conditions
- Invasive Candidiasis
- Keywords
- empirical antifungal therapy, invasive candidiasis, biomarkers, de-escalation, ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 29 May 2018 (actual)
- 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.
Empirical antifungal therapy (EAT) is frequently prescribed to septic critically ill patients with risk factors for invasive Candida infections (ICI). However, among patients without subsequent proven ICI, antifungal discontinuation is rarely performed, resulting in unnecessary antifungal overuse.
The investigators postulate that the use of fungal biomarkers could increase the percentage of early discontinuation of EAT among critically ill patients suspected of ICI, as compared with a standard strategy, without negative impact on day 28-mortality.
To test this hypothesis, the investigators designed a randomized controlled open-label parallel-group study.
Detailed description
Patients requiring EAT will be randomly assigned to:
- intervention group: a strategy in which EAT duration is determined by (1,3)-B-Dglucan and mannan serum assays, performed on day 0 (day of EAT initiation) and day 3. Early stop recommendation, provided before day 7, will be determined using an algorithm based on the results of biomarkers.
- control group: a routine care strategy, based on international guidelines, which recommend 14 days of treatment for patients without subsequent proven ICI, and who improve under antifungal treatment, or less in other situations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biomarker group | Other | Other: Biomarker strategypatient follow the Biomarker strategy |
| Routine group | Other | Other: Routine strategypatient follow the routine strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient older than 18 years
- Who require EAT for the first time in the ICU (this treatment is prescribed based on the presence of risk factors and clinical suspicion of ICI)
- With an expected ICU length of stay of at least 6 days after EAT initiation
- Informed written consent
Key exclusion criteria (6 listed)
- Neutropenia (neutrophil count <500 cells /µL)
- Active malignant hemopathy
- Bone marrow transplantation in the last 6 months
- Polyvalent immunoglobulins in the past months
- Documented ICI in the past 3 months
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 strategyEAT duration is determined by β-D-1,3-glucan and mannan serum assays, performed at day 0 (day of EAT initiation) and day 3. | Other | Biomarker group |
| Routine strategyEAT duration is based on IDSA guidelines, which recommend 14 days of treatment for patients without subsequent proven ICI, and who improve under antifungal treatment, or less in other situations. | Other | Routine group |
Primary outcome
percentage of patients receiving early discontinuation of EAT, defined as a discontinuation strictly before day 7 after EAT initiation
Time frame: day 7 after EAT initiation
This trial is designed to demonstrate whether, in critically ill patients suspected for ICI, the biomarker strategy, as compared with a standard strategy, is at the same time: 1. superior in terms of antifungal use and 2. Non-inferior in terms of death
13 secondary outcomes
death from any cause
Time frame: day 28 after EAT initiation
percentage of patients who presented a proven ICI after EAT discontinuation
Time frame: at day 28 or ICU discharge, if it occurs before day 28
percentage of patients who received at least two periods of antifungal treatment (prescribed for separate episodes of suspected or proven ICI)
Time frame: at day 28 or ICU discharge, if it occurs before day 28
intensity of Candida colonization during ICU stay
Time frame: at day 28 or ICU discharge, if it occurs before day 28
percentage of patients colonized with a resistant strain of Candida
Time frame: at day 28 or ICU discharge, if it occurs before day 28
antifungal-free days
Time frame: at day 28 or ICU discharge, if it occurs before day 28
ventilator-free days
Time frame: at day 28 or ICU discharge, if it occurs before day 28
ICU-free days
Time frame: at day 28 or ICU discharge, if it occurs before day 28
ICU mortality
Time frame: at day 28 or ICU discharge, if it occurs before day 28
day 90 mortality
Time frame: at day 90
Characterization of the fungal intestinal microbiota studied by standard mycology
Time frame: at baseline, at Day 7, day 14 day 21 and day 28
Characterization of the fungal intestinal microbiota studied by metagenomics
Time frame: at baseline, at Day 7, day 14 day 21 and day 28
Characterization of the bacterial intestinal microbiota studied by culture bacteriology
Time frame: at baseline, at Day 7, day 14 day 21 and day 28
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 19 May 2026.
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Comparison of Uncomplicated Candidemia Therapy Duration in Children and Adults
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A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
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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.
Anahita Rouze, MD principal investigator
University Hospital, Lille
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomarker strategy and Routine strategy in people with Invasive Candidiasis, run by University Hospital, Lille at 10 sites 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 4 inclusion and 6 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 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 patients receiving early discontinuation of EAT, defined as a discontinuation strictly before day 7 after EAT initiation (time frame: day 7 after EAT initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2026.