A Randomized Controlled Trial of Oseltamivir in Outpatients With Chronic Pulmonary Disease: a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- non-elective admission to hospital
研究概览
简要总结
The proposed pilot study will provide needed data to establish the feasibility of a conducting a large randomized controlled trial as to the effectiveness of the use of oseltamivir early in the course of influenza in outpatients with chronic pulmonary disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinic patients with physician diagnosed chronic obstructive pulmonary disease
- •respirologist-diagnosed non-cystic fibrosis bronchiectasis and pulmonary fibrosis (based on appropriate clinical, exposure, and radiological criteria as per American Thoracic Society guidelines)
- •Participants will be drawn from the respirology clinics and will be randomized if within 72 hours of meeting criteria for influenza-like illness
排除标准
- •residents of nursing homes
- •patients who are immunosuppressed
- •patients on immunosuppressive does (15 mg or more) of prednisone for three weeks or longer
研究组 & 干预措施
oseltamivir
75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset
干预措施: oseltamivir (Drug)
Placebo
75mg placebo calcium carbonate pills taken twice daily for five days within 72 hours of symptom onset and will be identical in appearance to oseltamivir
干预措施: Placebo (Other)
结局指标
主要结局
non-elective admission to hospital
时间窗: up to 28 days following randomization
A non-elective admission to hospital, in contrast to visits to the emergency department where admission does not take place. However, a prolonged stay in the emergency department (\> 24 hours) will also be considered to be hospitalization. Events that occur beyond this time period are deemed unlikely to be directly related to influenza,except functional status which will be assessed up to three months following acute respiratory infection. Secondly, the hospitalization must also be considered to be due to acute respiratory illness. An adjudication committee (comprised of two infectious diseases physicians who also practice general internal medicine) blinded to study group allocation will review data for hospitalization. They will be asked to judge whether the hospitalization was definitely or probably related to the acute respiratory illness. Those judged to be definitely or probably related will be considered as our primary outcome.
次要结局
- lower respiratory tract infection(up to 28 days following randomization)