Determining Elements of Anti-Fungal Immunity in BURN Patients (DEFI-BURN)

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 Overview

• Status: Recruiting
• Conditions: Burn
• Intervention / Treatment: Other: Biological sampling

• Study Type: Observational
• Enrollment (Estimated): 327

Contacts and Locations

• Study Contact: Name: Jérôme Lambert, MD PhD; Phone Number: +33 +33142499742; Email: jerome.lambert@u-paris.fr
• Study Contact Backup: Name: Emmanuel Dudoignon, MD; Phone Number: +33 1 42 49 93 94; Email: emmanuel.dudoignon@aphp.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • Hôpital Saint Louis AP-HP
    • Contact: Emmanuel Dudoignon; Phone Number: +33 +331 42 49 94 31; Email: emmanuel.dudoignon@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with burn injury

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy
• Opposition of the patient or his/her relatives
• Decision not to resuscitate or to limit or stop active therapies

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult patients with burn injury	Other: Biological sampling; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		At day 30
Overall survival		At day 90
Hospital mortality		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	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.	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.	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.	At inclusion
Number of days without renal replacement therapy		At day 30
Number of days without mechanical ventilation		At day 30
Length of stay in Intensive Care Unit		Up to 18 months
Length of stay in hospital		Up to 18 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2025
• Primary Completion (Estimated): October 23, 2030
• Study Completion (Estimated): October 23, 2030

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): February 14, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: APHP241672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No