Comparative Effectiveness of Baloxavir Versus Oseltamivir for Influenza Outbreak Management in U.S. Nursing Homes
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Total number of ILI cases defined, following the index influenza case identification in nursing homes randomized to baloxavir or oseltamivir
研究概览
简要总结
Influenza outbreaks are a prevalent event in nursing homes (NHs). We will study baloxavir compared to oseltamivir when used for influenza prophylaxis when facilities identify an index incident case of influenza. This study will help guide nursing home's decision making and demonstrate the effectiveness of a novel antiviral for preventing influenza outbreaks.
详细描述
A random study sample of about 1000 U.S. nursing homes (NHs), housing approximately 112,000 overall residents and 92,000 over the age of 65 years, of whom 64,500 are long-stay NH residents, will be recruited for the study. Participating facilities will be randomly allocated in a 1:1 ratio to oseltamivir or baloxavir for antiviral treatment and prophylaxis. Primary study data provided by facilities monthly during the influenza season will support primary and secondary endpoints along with administrative claims and public use datasets containing information on facility characteristics.
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
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medicare-certified NHs in any location in the United States with at least 50 long-stay residents 18 years of age or older.
排除标准
- •Hospital-based facilities
- •Facilities not submitting MDS data
研究组 & 干预措施
Oseltamivir
Nursing homes randomized to receive oseltamivir for treatment and chemoprophylaxis for influenza.
干预措施: Oseltamivir (Drug)
Baloxavir
Nursing homes randomized to receive baloxavir for treatment and chemoprophylaxis for influenza.
干预措施: Baloxavir (Drug)
结局指标
主要结局
Total number of ILI cases defined, following the index influenza case identification in nursing homes randomized to baloxavir or oseltamivir
时间窗: Up to 8 months each influenza season
To demonstrate the non-inferiority of prophylactic baloxavir vs. oseltamivir to prevent influenza-like illness (ILI) after an index influenza case in nursing homes.
次要结局
- Hospitalizations from Minimum Data Set (MDS) 3.0 (interim) and Medicare A claims(Up to 8 months each influenza season)
- Outbreak duration defined as the time of the first laboratory-confirmed case of influenza to 7 days following the last identified case of influenza-like illness requiring treatment with baloxavir or oseltamivir(Up to 8 months each influenza season)
- Facility-level data on antiviral courses of treatment administered from Medication Administration Records(Up to 8 months each influenza season)
- Mortality from Medicare Vital Status File(Up to 8 months each influenza season)