Determining Elements of Anti-Fungal Immunity in BURN Patients

Not yet recruiting

• Conditions: Burn

• Registration Number: NCT06828458
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14
• Study Start: 2025-03-01
• Primary Completion: 2030-09-01
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 327

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Invasive fungal disease (IFD) onset during hospitalisation time	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.

Secondary Outcome Measures

Name	Time	Method
Length of stay in Intensive Care Unit	Up to 18 months
Length of stay in hospital	Up to 18 months
Hospital mortality	Up to 18 months
Overall survival	At day 90
Incidence of organ failure during hospitalisation	Up to 18 months	* 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
Severity score at admission	At inclusion	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.
Number of days without renal replacement therapy	At day 30
Number of days without mechanical ventilation	At day 30