Determining Elements of Anti-Fungal Immunity in BURN Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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