NCT00436124终止4 期
A Randomized, Open Label Study to Evaluate the Effect of Tamiflu on Viral Shedding and on Serum and Cytoplasmic Inflammatory Cytokine Concentrations in Patients With Laboratory-confirmed Influenza
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 试验地点
- 1
- 主要终点
- Viral shedding; serum and intracellular concentrations of inflammatory cytokines (INFgamma, TNFalpha, IL-6, IL-12).
研究概览
简要总结
This study will evaluate the efficacy and safety of Tamiflu in patients with clinically-diagnosed influenza occurring during an influenza outbreak within the community. Patients will be randomized to receive Tamiflu 75mg bid orally plus support therapy (NSAIDs and antibiotics) or support therapy alone. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
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
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-64 years of age;
- •ambulatory;
- •influenza-like illness;
- •positive rapid assay for detection of influenza antigen.
排除标准
- •presentation >36h after onset of symptoms;
- •influenza-like symptoms outside an outbreak based on local surveillance activities;
- •influenza vaccination between November 2006 and January 2007;
- •receipt of antiviral therapy, systemic steroids or immunosuppressants within 2 weeks prior to study day 1.
结局指标
主要结局
Viral shedding; serum and intracellular concentrations of inflammatory cytokines (INFgamma, TNFalpha, IL-6, IL-12).
次要结局
- Efficacy: Duration of illness, health and functional status, extent and severity of symptoms, incidence of resistant viruses. Safety: AEs.
研究者
研究点 (1)
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