Real-World Effectiveness of Nirsevimab Against RSV-Related and All-Cause Respiratory Tract Infections in Chinese Infants: A Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 816
- 试验地点
- 7
- 主要终点
- Incidence of RSV-related LRTI hospitalization.
研究概览
简要总结
A multicenter, retrospective cohort study based on clinical data from seven tertiary hospitals in China will be undertaken. The study aims to evaluate the real-world effectiveness of Nirsevimab in preventing Respiratory Syncytial Virus (RSV) infections and all-cause respiratory infections. Clinical records will be used to compare outcomes between infants who received Nirsevimab and a control group. The study focuses on infants aged 0 to 1 year during the RSV season.
详细描述
The purpose of this study is to evaluate the effectiveness of Nirsevimab in preventing RSV-related and all-cause lower respiratory tract infections (LRTI) among infants in a real-world setting.
The target population includes infants aged 0 to 1 year enrolled across seven Chinese tertiary hospitals during the RSV season (September 2024 through April 2025). The study employs a target trial emulation design to compare infants receiving Nirsevimab with a control group of infants who did not receive Nirsevimab.
Outcomes will be assessed over a follow-up period of up to 180 days. Researchers will utilize hospital electronic medical records to identify the incidence of infections, hospitalizations, and admissions to the intensive care unit (ICU). Statistical methods, such as inverse probability of treatment weighting, will be applied to balance the characteristics of the two groups and ensure a valid comparison.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants aged ≤ 1 year (including preterm infants) entering their first RSV season.
排除标准
- •Prior or active RSV infection.
- •Prior RSV immunization (maternal vaccine or monoclonal antibody).
研究组 & 干预措施
Nirsevimab group
Infants who received Nirsevimab during the study period.
干预措施: Nirsevimab (Biological)
Control group
Infants with health records established at the same study centers during the study period who were eligible for Nirsevimab but did not receive the immunization.
结局指标
主要结局
Incidence of RSV-related LRTI hospitalization.
时间窗: From enrollment up to 180 days.
Number of participants admitted to the hospital (inpatient care) with a diagnosis of LRTI and a laboratory-confirmed RSV infection (detected by PCR or antigen testing).
次要结局
- Incidence of all-cause LRTI hospitalization.(From enrollment up to 180 days.)
研究者
Han Tongyan
Chief Physician
Peking University Third Hospital