NCT06528444招募中3 期
Randomized, Double-blind, Multicenter, Phase III Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza
Instituto de Investigación Sanitaria y Biomédica de Alicante2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- To compare the percentage of patients hospitalized
研究概览
简要总结
Clinical trial with an active ingredient of a pharmaceutical specialty marketed in Spain vs. placebo.
Randomized, double-blind, multicenter phase III clinical trial that evaluates the efficacy and safety of dexamethasone compared to placebo in patients with severe influenza.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 18 years.
- •Diagnosis of influenza A or B virus infection by antigen or RT-PCR (local laboratory) at the time of entry or at 48 hours prior to randomization in respiratory specimens (nasopharyngeal swab or bronchoalveolar lavage).
- •Hospitalized patients with an estimated hospital stay of more than 24 hours.
- •In previous treatment or concomitant start of treatment with oseltamivir.
- •For women of childbearing age, use of contraceptive methods until day 30 after completion of treatment.
- •Signed informed consent.
排除标准
- •Patients with bronchial hyperresponsiveness that requires systemic corticosteroids for more than 24 hours.
- •Pre-inclusion treatment with corticosteroids for more than 24 hours at a dose equal to or higher than 1 mg/kg methyl-prednisolone (0.2 mg/kg dexamethasone or 1.25 mg/kg prednisone).
- •Inability to administer oral oseltamivir.
- •Patients on ECMO (extracorporeal membrane oxygenation).
- •Pre-existing condition or use of medication that, in the opinion of the local investigator, may pose a risk for the administration of corticosteroids.
- •Patients with severe comorbidity with life expectancy of less than six months in the opinion of the investigator.
- •Patients co-infected with SARS-CoV-2 or RSV.
研究组 & 干预措施
dexamethasone
Active Comparator
dexamethasone 1 capsule (6 mg)/day for 7 days
干预措施: Grup 2 dexametasona (Drug)
Placebo
Placebo Comparator
placebo 1 capsule (6 mg) /day for 7 days.
干预措施: Grup 1 placebo (Drug)
结局指标
主要结局
To compare the percentage of patients hospitalized
时间窗: 10 days
To compare the percentage of patients hospitalized with influenza according to treatment arm (oseltamivir-dexamethasone vs oseltamivir-placebo) with status 3 or higher according to the Hospital Recovery Scale (status 3: hospitalization with supplemental oxygen, or 4: ICU admission without invasive mechanical ventilation, or 5: with invasive mechanical ventilation, or 6: death) on day 7 after the start of treatment.
次要结局
- Common Terminology Criteria for Adverse Events (CTCAE) scale(10 days)
- The National Early Warning Score(10 days)
- To evaluate the impact of steroid treatment on the evolution of the nasal microbiome expressed in alpha diversity.(10 days)
- the kinetics of influenza virus in nasopharyngeal swabs using Ct(10 days)
- Evaluation inflammatory markers PCT(10 days)
- the kinetics of influenza virus in nasopharyngeal swabs using viral quantification per human cell(10 days)
- Number of pacients in ICU admission(10 days)
- the impact of treatment Barthel Index(90 days)
- Evaluation inflammatory markers IL-10(10 days)
- Rate of metabolic impact of dexamethasone(10 days)
- the average hospital stay(10 days)
- the impact of treatment Clinical Frailty Score(90 days)
- Evaluation inflammatory markers CRP(10 days)
- mortality(90 days)
- Evaluation inflammatory markers IL-6(10 days)
研究者
研究点 (2)
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