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NCT Number: NCT06828458

Determining Elements of Anti-Fungal Immunity in BURN Patients

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.

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Key information

Conditions

Burn Burns Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological sampling

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

Primary outcomes

  1. Invasive fungal disease (IFD) onset during hospitalisation time

    Time frame: 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 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

    Time frame: 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

  5. Severity score at admission

    Time frame: 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.

  6. Severity score at admission

    Time frame: At inclusion

    ABSI Acute Bowel Ischemia Severity Index The score ranges from 0 to 10. A higher score indicates a more severe case and a higher risk of mortality.

  7. Severity score at admission

    Time frame: At inclusion

    SOFA score : Sequential Organ Failure Assessment The score can range from 0 to 24, with higher scores indicating more severe organ failure and a worse prognosis.

  8. Number of days without renal replacement therapy

    Time frame: At day 30

  9. Number of days without mechanical ventilation

    Time frame: At day 30

  10. Length of stay in Intensive Care Unit

    Time frame: Up to 18 months

  11. Length of stay in hospital

    Time frame: Up to 18 months

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuel Dudoignon, MD

CONTACT

[email protected]

1 42 49 93 94 ext. +33

Jérôme Lambert, MD PhD

CONTACT

[email protected]

+33142499742 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: DEFI-BURN

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Feb 14, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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