Burn
Conditions
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.
Interventions
OTHERBiological 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
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | At day 30 | — |
| Hospital mortality | Up to 18 months | — |
| 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 | 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. |
| 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 | — |
Countries
France
Contacts
CONTACTEmmanuel Dudoignon, MD
CONTACTJérôme Lambert, MD PhD
Outcome results
None listed