A Phase 2, Pilot, Open-label, Randomized Study of the Antiviral Activity, Safety, and Tolerability of Intravenous Peramivir in Adult Hospitalized Subjects With Confirmed Influenza Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- change in influenza RNA load
研究概览
简要总结
Peramivir is the first intravenous neuraminidase inhibitor (NAI) available for treatment of uncomplicated influenza in adults. Data from placebo-controlled trials in outpatients have shown antiviral efficacy, safety, and tolerability. Although the unmet need for intravenous therapy lies mainly with patients hospitalized with complicated diseases, such data are limited because of feasibility and ethical considerations for placebo-controlled studies.
In this study, the investigators aimed to examine more specifically treatment effects of peramivir in adults hospitalized with influenza-associated lower respiratory tract complications (LRTC). Such findings may have important implications on clinical management.
详细描述
The primary objective was to assess the virologic response of peramivir in influenza-associated lower respiratory tract complications (LRTC). The secondary objective was to assess safety and tolerability. Adults confirmed with influenza by polymerase chain reaction (PCR) and/or immunofluorescence assays during the seasonal peaks of 2011-2014 were assessed for eligibility. Consented individuals were randomized to receive either peramivir 600mg every 24 hourly or 300mg every 12 hourly for 5 days. In subjects not achieving clinical resolution by day 5, the same regimen could be continued until day 10 (virologic results unknown to clinicians).Renal-dosage adjustment, if required, was performed according to protocol.
The study's primary endpoint was change in influenza RNA load over time. The secondary endpoints were viral shedding indicated by culture and RNA negativity at day 5, and drug tolerability.
Additionally, a priori comparisons of these endpoints with historical controls treated with standard courses of oral oseltamivir (75mg bid for 5 days) in the same clinical settings were performed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptoms/signs of influenza, and
- •confirmation of lower respiratory tract infection (e.g. radiographic pneumonia, dyspnea caused by acute exacerbation of underlying airway diseases, bronchitis, or combinations).
排除标准
- •late presentation >1 week from onset,
- •hemodynamic instability,
- •hepatic/renal failure,
- •dialysis,
- •immunosuppression (e.g. transplant, chemotherapy), and
- •pregnancy.
研究组 & 干预措施
Peramivir 300mg Q12H
Peramivir 300 mg, administered intravenously, twice daily (every 12 hours)
干预措施: Peramivir (Drug)
Peramivir 600mg Q24H
Peramivir 600 mg, administered intravenously, once daily (every 24 hrs)
干预措施: Peramivir (Drug)
结局指标
主要结局
change in influenza RNA load
时间窗: 5 days
5-10 days
次要结局
- viral shedding indicated by PCR and culture negativity(5 days)
研究者
Prof David Shu Cheong Hui
Professor
Chinese University of Hong Kong