Determining Elements of Anti-Fungal Immunity in BURN Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biological sampling.
- Who it may be relevant to
- Registry conditions: Burn. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other 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
Primary outcome measures
- Invasive fungal disease (IFD) onset during hospitalisation time [Time frame: Up to 18 months]
Secondary outcome measures (11)
- Overall survival [Time frame: At day 30]
- Overall survival [Time frame: At day 90]
- Hospital mortality [Time frame: Up to 18 months]
- Incidence of organ failure during hospitalisation [Time frame: Up to 18 months]
- Severity score at admission [Time frame: At inclusion]
- Severity score at admission [Time frame: At inclusion]
- Severity score at admission [Time frame: At inclusion]
- Number of days without renal replacement therapy [Time frame: At day 30]
- Number of days without mechanical ventilation [Time frame: At day 30]
- Length of stay in Intensive Care Unit [Time frame: Up to 18 months]
- Length of stay in hospital [Time frame: Up to 18 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Saint Louis AP-HP — Paris
Identifiers
NCT: NCT06828458 · APHP241672