Determining Elements of Anti-Fungal Immunity in BURN Patients

NCT ID: NCT06828458

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 327 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2030-09-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adult patients with burn injury

Biological sampling

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Emmanuel Dudoignon, MD

Role: CONTACT

emmanuel.dudoignon@aphp.fr

1 42 49 93 94 ext. +33

Jérôme Lambert, MD PhD

Role: CONTACT

jerome.lambert@u-paris.fr

+33142499742 ext. +33

Other Identifiers

APHP241672

Identifier Type: -

Identifier Source: org_study_id