EUCTR2016-001008-49-Outside-EU/EEA进行中(未招募)1 期
A randomized, multicenter trial of oseltamivir doses of 75 mg for 5 or 10 days versus 150 mg for 5 or 10 days in influenza patients with pandemic (H1N1) 2009
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Pediatric, adolescent and adult patients >/=1 year of age
- •- Fever >/=37.8 degrees C or at least one respiratory symptom (cough, coryza, sore throat, or rhinitis)
- •- Positive rapid diagnostic test for pandemic (H1N1) 2009 virus or influenza A in the 24 hours prior to the first dose of study drug
- •- Are the trial subjects under 18? yes
- •Number of subjects for this age range: 200
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •- Currently receiving any form of renal replacement therapy including hemodialysis, peritoneal dialysis, or hemofiltration
- •- History of chronic renal failure or clinical suspicion of renal failure at baseline
- •- Clinical evidence of hepatic compensation at the time of randomization
- •- Known HIV infection
- •- Vaccination with live attenuated influenza vaccine (LAIV) in the two weeks prior to first dose of study medication
研究者
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