NCT01052961已完成4 期
Initiating Oseltamivir in Adults Hospitalized With Influenza -- a Study on the Impact of Virological Clearance and Clinical Recovery for Higher-dose Treatment Started Within 96 Hours
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- rate of influenza virus load decline and viral RNA negativity upon receiving 5 days of study treatment
研究概览
简要总结
Adult patients hospitalized with influenza have higher viral loads and more severe illnesses. Thus more aggressive treatment approaches (e.g. higher dose oseltamivir) have been suggested to treat patients suffering from severe influenza infection.
The investigators plan to investigate the impact of higher-dose oseltamivir (150 mg b.d.) treatment on viral clearance and clinical recovery in adult patients hospitalized for severe influenza. Such information may lead to optimization of the management strategy used for these patients.
详细描述
- The investigators plan to study the impact of higher-dose oseltamivir (150 mg b.d.) treatment on rate of viral load decline and RNA negativity (in nasal and throat swabs, assessed by quantitative RT-PCR assay) and time to clinical recovery in adult patients hospitalized for severe influenza.
- Patients who received intervention (oseltamivir 150 mg b.d. for 5 days) will be compared to those in the non-intervention arm (patients may receive oseltamivir treatment at 75 mg b.d. for 5 days, decided by their managing physicians) in the two respective study sites. Viral load changes and viral clearance will be compared. Clinical progress and time to symptom recovery will be reported. The protocol will be crossed-over to the other site at a defined time frame.
- oseltamivir 150 mg b.d. has been shown to be safe and well-tolerated in earlier clinical trials
- higher-dose treatment has been suggested by health authorities (e.g. WHO) to treat severe influenza infection/pneumonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed influenza A (H1N1, H3N2) or B infection by IFA or RT-PCR, with a compatible clinical illness
- •presented within 96 hours from symptom onset
- •age >/= 18 years
排除标准
- •lack of consent
- •suspected avian influenza
- •patients who have received antivirals against influenza prior to admission
- •suspected or confirmed oseltamivir resistance
- •pre-existing renal impairment, with creatinine clearance <40 ml/min
- •pre-existing hepatic failure
- •participation in a clinical study involving experimental medication in the past 4 weeks
- •pregnant women, or who are attempting to become pregnant, or who are breast feeding.
研究组 & 干预措施
oseltamivir, higher dose
Active Comparator
oseltamivir 150 mg bd for 5 days for patients presented within 96 hours from onset
干预措施: Oseltamivir (Drug)
结局指标
主要结局
rate of influenza virus load decline and viral RNA negativity upon receiving 5 days of study treatment
时间窗: during and upon completion of the 5-day study treatment
次要结局
- time to clinical recovery (including symptoms, vital signs, hospital discharge)(during and upon completion of the 5-day study treatment)
研究者
Nelson Lee
Professor
Chinese University of Hong Kong
研究点 (1)
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