A Double-blind, Randomized, Placebo Controlled, Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 477
- 主要终点
- Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population
研究概览
简要总结
This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.
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
- Double (Participant, Investigator)
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
- •Negative rapid diagnostic test for influenza at baseline;
- •Immunocompromised participant (liver and/or kidney recipient or allogenic hematopoietic stem cell transplant).
排除标准
- •Symptoms suggestive of influenza-like illness; but not limited to fever, cough, or nasal congestion;
- •Influenza vaccination in 6 weeks prior to randomization;
- •Positive rapid diagnostic test for influenza;
- •Solid organ transplant within 6 months of randomization;
- •Antiviral treatment for influenza in 2 weeks prior to randomization.
研究组 & 干预措施
Oseltamivir
干预措施: Oseltamivir (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population
时间窗: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than \[\>\] 37.2 degrees Celsius \[°C\]) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum hemagglutination inhibition (HAI) titers measured from baseline to any point during the study.
次要结局
- Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population(From baseline up to 28 days after the last dose of study drug (maximum up to 112 days))
- Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population(From baseline up to 28 days after the last dose of study drug (maximum up to 112 days))
- Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population(From baseline up to 28 days after the last dose of study drug (maximum up to 112 days))
- Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population(From baseline up to 28 days after the last dose of study drug (maximum up to 112 days))
- Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population(From baseline up to 28 days after the last dose of study drug (maximum up to 112 days))
- Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population(From baseline up to 28 days after the last dose of study drug (maximum up to 112 days))