Health TrialsbyHealthPanel

Determining Elements of Anti-Fungal Immunity in BURN Patients

ConditionBurn
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Opposition of the patient or his/her relatives

Decision not to resuscitate or to limit or stop active therapies

Trial population

Adult patients with burn injury

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biological sampling

    Other intervention

    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

Treatment groups

327 Participants
are divided into 1 treatment group
Group A: Adult patients with burn injury1 intervention

Trial outcomes

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.

Time frame
Up to 18 months

Secondary outcomes

1

Overall survival

Time frame
At day 30
2

Overall survival

Time frame
At day 90
3

Hospital mortality

Time frame
Up to 18 months
4

Incidence of organ failure during hospitalisation

* 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

Time frame
Up to 18 months

Other outcomes

Sponsors and contacts

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Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov
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