2024-515275-35-00招募中3 期
Evaluating the Therapeutic Efficacy of Filgrastim in Severe Bullous Drug Eruptions (Lyell and Stevens-Johnson Syndromes)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Comparison between the 2 groups of the proportion of patients with a halt in the progression of skin detachment at D5 (D0: initiation of treatment) defined by a detached and/or bullous surface and/or associated with a NIKOLSKY sign determined according to the stable burns table
研究概览
简要总结
Compare, after 5 days of treatment, the cessation of disease progression in patients with SJS/NET between the experimental arm receiving filgrastim in addition to the reference symptomatic treatment (FILGRASTIM group) and the control arm receiving only the reference symptomatic treatment combined with placebo (CONTROL group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Filgrastim (ZARZIO) / Placebo (Glucose 5%)
- 盲法
- Single (Subject)
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Patient 6 years of age and older, presenting with SJS or NET of proven or very strongly suspected (indirect argument of certainty) drug or infectious origin, confirmed by the evaluator
- •SJS or NET evolving for less than 7 days and with progression of the detachment or rash observed within 48 hours
- •Patient and/or guardians capable of understanding the objectives of the trial and having given written consent to participate (parents for minors, guardians for patients in immediate life-threatening situations)
- •Patient registered with a social security scheme or benefiting from a similar scheme
- •Negative beta-HCG pregnancy test for women of childbearing age
排除标准
- •Patients weighing less than 20 kg
- •Known hypersensitivity to the active substance (FILGRASTIM) or to the one of the excipients (glutamine acid, sorbitol E420, Polysorbate 80)
- •Patients with known glucose intolerance or hereditary fructose intolerance
- •Patient with a traumatic brain injury less than 24 hours
- •Patients in septic shock
- •Chronic myeloid disease such as myeloid leukemia or AML
- •Thrombophilia or current thrombosis pathology
- •PNN (polymorphonuclear neutrophils) > 50.000 on the CBC (Complete Blood Count) during the inclusion visit
- •Administration of G-CSF or GM-CSF within 5 days of inclusion
- •Patient who received cyclosporine, anti-TNFalpha or intravenous immunoglobulins or lithium in the month prior the inclusion
- •Pregnant or breast-feeding women
- •Patient under protective measure (safeguard measure, curatorship, guardianship) or deprived of liberty
- •Patient in exclusion period after participation at other interventional clinical trial
结局指标
主要结局
Comparison between the 2 groups of the proportion of patients with a halt in the progression of skin detachment at D5 (D0: initiation of treatment) defined by a detached and/or bullous surface and/or associated with a NIKOLSKY sign determined according to the stable burns table
Comparison between the 2 groups of the proportion of patients with a halt in the progression of skin detachment at D5 (D0: initiation of treatment) defined by a detached and/or bullous surface and/or associated with a NIKOLSKY sign determined according to the stable burns table
次要结局
- Overall survival at D30
- Overall survival to D365
- Number of hospital days corresponding to the length of hospitalization for the SJS/NET episode
- Time to stop progression
- Time to complete re-epidermalization, defined as disappearance of skin erosions AND return to normal skin
- Number per patient and nature of clinical or biological adverse events observed between D0 and D5 leading to premature discontinuation of filgrastim treatment
- Total number per patient and nature of clinical or biological adverse events observed up to D365
- Use of systemic corticosteroid therapy between D0 and D15, with a study of the nature, cumulative doses and indications for objective prescriptions. A comparison will be made between the 2 treatment groups.
- Presence of ophthalmological, stomatological/ORL, gastroenterological, gynecological, urological and psychiatric sequelae
- Patient quality of life
- Risk of developing post-traumatic stress disorder (PTSD)
研究者
Benoît BEN SAID
Scientific
Hospices Civils De Lyon
研究点 (1)
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