BurnDEFI-BURNNCT06828458
Determining Elements of Anti-Fungal Immunity in BURN Patients
An observational study of Burn, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Scientific justification Invasive fungal diseases (IFDs) pose a substantial threat, especially in immunocompromised patients, necessitating urgent research focus and therapeutic advancements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn
- What is being tested?
- Biological sampling
- How many people
- 327 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2025to 23 Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adult patients with burn injury
Who may be able to join
- Burn patients
- Adult patients ≥ 18 years old
- Admission < 4 days following burn injury
- Total burn surface Area ≥ 15%
- Non opposition of the patient or his/her relatives to the research
- Affiliation to social security or any health insurance
Who cannot join
- Pregnancy
- Opposition of the patient or his/her relatives
- Decision not to resuscitate or to limit or stop active therapies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Saint Louis AP-HP
Paris
Emmanuel Dudoignon, +331 42 49 94 31 ext. +33, emmanuel.dudoignon@aphp.fr
About this study
Scientific justification Invasive fungal diseases (IFDs) pose a substantial threat, especially in immunocompromised patients, necessitating urgent research focus and therapeutic advancements. The IFI-BURN study, involving a cohort of patients with severe burn injury (n=276), revealed a significant IFD incidence of 31.6% and underscored their critical impact on morbidity and mortality. While fungi are present everywhere, for moulds within the environment and for yeasts within our microbiota, why certain patients develop IFDs and others do not, remains poorly understood. The answer most likely resides in the impact of the burn injury on the immune response, loss of skin barrier and particular predisposing immune phenotype of patients. The immune system is composed of both cellular and humoral components, but the latter is far less studied in antifungal immunity although they exert multiple antimicrobial mechanisms.
- Conditions
- Burn
- Being tested
- Biological sampling
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplingOther
Whole blood on EDTA sample 2 tubes (5mL) PAXgene sample 1 tube (2.5 mL) Rectal swab Skin swab (1 swab for 5 anatomically burned sites)
At day 0, day 3, day 7, day 14, day 21
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with burn injury | Not described Receives: Other: Biological sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive fungal disease (IFD) onset during hospitalisation time
Proven IFD according to EORTC/MSGERC criteria applicable for invasive candidiasis. Putative invasive mold infection is defined with ≥ 2 positive culture from skin biopsy/bronchoalveolar lavage or ≥ 2 positive blood specific qPCR (aspergilosis, mucorales, fusariosis) or a combination of both. Possible invasive mold infection is defined with only one positive mycological criterion.
Measured: Up to 18 months
Secondary outcomes (11)
Overall survival
Measured: At day 30
Overall survival
Measured: At day 90
Hospital mortality
Measured: Up to 18 months
Incidence of organ failure during hospitalisation
- Acute respiratory distress syndrome defined by the modified Berlin criteria, or
- Acute kidney injury as defined by the KDIGO consensus, or
- Septic shock and doses of catecholamines defined by SEPSIS-3
Measured: Up to 18 months
Severity score at admission
SAPS 2 : Simplified Acute Physiology Score II The score can range from 0 to 163. Higher score indicates more severe illness and a higher risk of mortality. Lower score indicates less severe illness and a lower risk of mortality.
Measured: At inclusion
Severity score at admission
ABSI Acute Bowel Ischemia Severity Index The score ranges from 0 to 10. A higher score indicates a more severe case and a higher risk of mortality.
Measured: At inclusion
Severity score at admission
SOFA score : Sequential Organ Failure Assessment The score can range from 0 to 24, with higher scores indicating more severe organ failure and a worse prognosis.
Measured: At inclusion
Number of days without renal replacement therapy
Measured: At day 30
Number of days without mechanical ventilation
Measured: At day 30
Length of stay in Intensive Care Unit
Measured: Up to 18 months
Length of stay in hospital
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start23 Apr 2025
- Primary completion23 Oct 2030 (estimated)
- Study completion23 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 327 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828458
- Sponsor's protocol ID
- APHP241672
- Acronym
- DEFI-BURN
- Status last verified
- Apr 2026
- First submitted
- 10 Feb 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Elements of Anti-Fungal Immunity in BURN Patients
- ClinicalTrials.gov ID
- NCT06828458
- Acronym / sponsor ID
- DEFI-BURN / APHP241672
- Conditions
- Burn
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 327 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 23 Oct 2030 (estimated)
- Study completion
- 23 Oct 2030 (estimated)
- First posted
- 14 Feb 2025 (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.
Scientific justification Invasive fungal diseases (IFDs) pose a substantial threat, especially in immunocompromised patients, necessitating urgent research focus and therapeutic advancements. The IFI-BURN study, involving a cohort of patients with severe burn injury (n=276), revealed a significant IFD incidence of 31.6% and underscored their critical impact on morbidity and mortality. While fungi are present everywhere, for moulds within the environment and for yeasts within our microbiota, why certain patients develop IFDs and others do not, remains poorly understood. The answer most likely resides in the impact of the burn injury on the immune response, loss of skin barrier and particular predisposing immune phenotype of patients. The immune system is composed of both cellular and humoral components, but the latter is far less studied in antifungal immunity although they exert multiple antimicrobial mechanisms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with burn injury | – | Other: Biological sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with burn injury
Key inclusion criteria (6 listed)
- Burn patients
- Adult patients ≥ 18 years old
- Admission < 4 days following burn injury
- Total burn surface Area ≥ 15%
- Non opposition of the patient or his/her relatives to the research
Key exclusion criteria (3 listed)
- Pregnancy
- Opposition of the patient or his/her relatives
- Decision not to resuscitate or to limit or stop active therapies
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 |
|---|---|---|
| Biological samplingWhole blood on EDTA sample 2 tubes (5mL) PAXgene sample 1 tube (2.5 mL) Rectal swab Skin swab (1 swab for 5 anatomically burned sites) At day 0, day 3, day 7, day 14, day 21 | Other | Adult patients with burn injury |
Primary outcome
Invasive fungal disease (IFD) onset during hospitalisation time
Time frame: Up to 18 months
Proven IFD according to EORTC/MSGERC criteria applicable for invasive candidiasis. Putative invasive mold infection is defined with ≥ 2 positive culture from skin biopsy/bronchoalveolar lavage or ≥ 2 positive blood specific qPCR (aspergilosis, mucorales, fusariosis) or a combination of both. Possible invasive mold infection is defined with only one positive mycological criterion.
11 secondary outcomes
Overall survival
Time frame: At day 30
Overall survival
Time frame: At day 90
Hospital mortality
Time frame: Up to 18 months
Incidence of organ failure during hospitalisation
Time frame: Up to 18 months
Severity score at admission
Time frame: At inclusion
Severity score at admission
Time frame: At inclusion
Severity score at admission
Time frame: At inclusion
Number of days without renal replacement therapy
Time frame: At day 30
Number of days without mechanical ventilation
Time frame: At day 30
Length of stay in Intensive Care Unit
Time frame: Up to 18 months
Length of stay in hospital
Time frame: Up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 23 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel Dudoignon, MD (1 42 49 93 94 ext. +33, emmanuel.dudoignon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive fungal disease (IFD) onset during hospitalisation time (time frame: Up to 18 months). 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 23 Apr 2026.