Determining Elements of Anti-Fungal Immunity in BURN Patients

NCT06828458 | Recruiting

• 1 other identifier: APHP241672
• Study Type: observational
• Target: 327
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Overall survival

  At day 30

• Overall survival

  At day 90

• Hospital mortality

  Up to 18 months

• Incidence of organ failure during hospitalisation

  Up to 18 months

• Severity score at admission

  At inclusion

Study Arms (1)

Adult patients with burn injury

Other: Biological sampling

Interventions

Biological sampling OTHER

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

Adult patients with burn injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with burn injury

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint Louis AP-HP

Paris, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood Rectal swab skin swab

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Emmanuel Dudoignon, MD

CONTACT

1 42 49 93 94; emmanuel.dudoignon@aphp.fr

Jérôme Lambert, MD PhD

CONTACT

+33142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: April 23, 2025
• Primary Completion (Estimated): October 23, 2030
• Study Completion (Estimated): October 23, 2030
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

FR (1)