BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49,680
- 试验地点
- 1
- 主要终点
- Incidence of first episodes of polymerase chain reaction (PCR)-confirmed RSV with an lower respiratory tract disease (LRTD)
研究概览
简要总结
The primary objectives of the study are: To estimate the effectiveness of nirsevimab against polymerase chain reaction (PCR)-confirmed RSV (1) lower respiratory tract (LRTD) and (2) related medical encounters.
the secondary objectives are:
- To estimate the effectiveness of nirsevimab against medical encounters with a respiratory related diagnosis.
- To estimate the effectiveness of nirsevimab against medical encounters with an LRTD diagnosis.
- To estimate the impact of nirsevimab on PCR-confirmed RSV.
- To estimate the impact of nirsevimab on medical encounters with an otitis media diagnosis.
- To estimate the impact of nirsevimab on antibiotic prescription.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Days 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The Kaiser Permanente Northern California, USA (KPNC) member born on or after 01 April 2023 for Cohort 1 and Cohort
- •Eligible to receive nirsevimab as defined by the product indication.
- •KPNC infants entering their first RSV season.
排除标准
- •Mother was administered an RSV vaccine during her pregnancy with the infant participant.
- •Mother of infant participant was not a KPNC member during pregnancy.
- •Mother did not deliver the infant participant at a KPNC facility.
- •Infant receipt of other RSV pre-exposure prophylaxis (ie, Palivizumab).
- •Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
结局指标
主要结局
Incidence of first episodes of polymerase chain reaction (PCR)-confirmed RSV with an lower respiratory tract disease (LRTD)
时间窗: Approximately 6 months
Incidence of first episodes of polymerase chain reaction (PCR)-confirmed RSV with an lower respiratory tract disease (LRTD) diagnosis identified using International Classification of Diseases, Tenth Revision (ICD)
Number of medical encounters associated with the first episode of PCR-confirmed RSV with a LRTD diagnosis
时间窗: Approximately 6 months
Number of medical encounters associated with the first episode of PCR-confirmed RSV with a LRTD diagnosis identified using ICD-10 codes: outpatient (OP) visits, emergency department (ED) visits, inpatient (IP) hospitalizations or intensive care unit (ICU) hospitalizations.
次要结局
- Number of respiratory-related medical encounters for LRTD by ICD-10 codes(Approximately 6 months)
- Incidence of PCR-confirmed RSV (first occurrence of season)(Approximately 6 months)
- Number of medical encounters for otitis media by ICD-10 codes(Approximately 6 months)
- Number of antibiotic prescriptions by National Drug Code (NDC) codes(Approximately 6 months)
- Number of respiratory-related medical encounters(Approximately 6 months)