A Phase IIIb, Open-label, Comparative, Randomized Study on Resistance of Influenza A/H1N1 2009 Virus to Treatment With Oseltamivir at Standard Dose Versus Double Dose
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 37
- 主要终点
- Percentage of Participants Excreting Resistant Virus
研究概览
简要总结
This open-label randomized 2 arm study will determine the emergence of viral resistance in participants with seasonal influenza A infection treated with oseltamivir. Eligible participants less than or equal to (</=) 5 years of age will be randomized to receive oseltamivir at either standard dose (30-75 milligrams [mg] orally twice daily [bid]) or double dose (60-150 mg orally bid) for 5 days. Target sample size is greater than (>) 100.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •positive rapid antigen test for influenza A
- •onset of symptoms of influenza (fever, at least one respiratory symptom) </=48 hours
排除标准
- •clinical suspicion of infection with a respiratory virus other than influenza
- •suspicion of invasive bacterial infection
- •evidence of poorly controlled underlying disease
- •known immunosuppression
- •known allergy to Oseltamivir
- •women who are pregnant or planning to get pregnant during the study
研究组 & 干预措施
Standard Dose
Oseltamivir capsule will be administered orally at a dose of 75 mg BID in adult participants and children will receive oseltamivir powder for oral suspension dose (at 12 milligrams/ milliliter [mg/mL]) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
干预措施: Oseltamivir (Drug)
Double Dose
Oseltamivir capsule will be administered orally at a dose of 150 mg BID in adult participants and children will receive oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
干预措施: Oseltamivir (Drug)
结局指标
主要结局
Percentage of Participants Excreting Resistant Virus
时间窗: Day 5
Resistant virus included new influenza A virus subtype hemagglutinin type 1 and neuraminidase type 1 (New AH1N1).
次要结局
- Number of Participants With Various Clinical Signs and Symptoms(Day 5)
- Percentage of Participants With A Reduction in Viral Load(Baseline, Day 5)
- Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected(Day 5)