Determining Elements of Anti-Fungal Immunity in BURN Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 327
- 主要终点
- Invasive fungal disease (IFD) onset during hospitalisation time
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pregnancy
- •Opposition of the patient or his/her relatives
- •Decision not to resuscitate or to limit or stop active therapies
结局指标
主要结局
Invasive fungal disease (IFD) onset during hospitalisation time
时间窗: 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.
次要结局
- Hospital mortality(Up to 18 months)
- Overall survival(At day 90)
- Incidence of organ failure during hospitalisation(Up to 18 months)
- Severity score at admission(At inclusion)
- Number of days without renal replacement therapy(At day 30)
- Length of stay in hospital(Up to 18 months)
- Number of days without mechanical ventilation(At day 30)
- Length of stay in Intensive Care Unit(Up to 18 months)