2025-524976-40-00招募中3 期
ECSIP : Early Corticosteroids in Severe Influenza Pneumonia, a phase III randomized controlled trial
Centre Hospital Region Metz Thionville48 个研究点 分布在 1 个国家目标入组 544 人开始时间: 2026年9月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 544
- 试验地点
- 48
研究概览
简要总结
To compare the efficacy of dexamethasone versus placebo in patients with severe influenza on a hierarchical composite endpoint of all-cause mortality, number of ventilator-free days and number of ICU-free days between day 0 and day 28.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Admission to ICU or intermediate care for less than 2 days
- •Admission to hospital for less than 5 days
- •Diagnosis of influenza pneumonia with • PCR positive for Influenza dated less than 5 days • AND focal shadowing/infiltrates on chest X-ray or CT-scan • AND at least one of the following: cough, purulent sputum, chest pain or dyspnoea
- •Requirement of supplemental oxygen at a flow rate of at least 3 L/min OR non-invasive ventilation OR high flow oxygen therapy OR invasive mechanical ventilation.
- •Written informed or emergency consent
- •Ongoing medical insurance
排除标准
- •Moribund state
- •Patient at risk of strongyloidiasis
- •Subject with shock on enrolment and on ongoing vasopressor therapy (≥ 0.25 microg/kg/min)
- •Indication for corticosteroid therapy in a dosage above 0.5 mg/kg/day prednisone-equivalent
- •Subject deprived of liberty or under a legal protective measure (example: patients under guardianship or curatorship)
- •Pregnant or breastfeeding woman
- •Lack of clinical equipoise by the attending physician and/or the presence of a substantial risk associated with the patients’ participation in the trial.
- •Bone marrow transplant or chemotherapy-induced neutropenia
- •Known allergy to dexamethasone or to one of its excipients
- •Uncontrolled psychotic states
- •Pheochromocytoma
- •Co-infection with COVID-19
- •Cardiogenic shock secondary to influenza myocarditis
- •Known active tuberculosis or fungal infection
- •Active viral hepatitis or active herpes virus infection
研究者
LOUIS Guillaume
Scientific
Centre Hospital Region Metz Thionville
研究点 (48)
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