Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,140
- 试验地点
- 5
- 主要终点
- Proportion of patients passively immunised with nirsevimab
研究概览
简要总结
Respiratory tract infections caused by respiratory syncytial virus (RSV) are a worldwide burden and represent a major public health issue. In France, bronchiolitis is responsible for around 100,000 emergency room visits and 50,000 hospital admissions every year; 75% of infants hospitalised for RSV bronchiolitis are healthy full-term children.
Recent discoveries concerning the specific viral epitopes of RSV have made it possible to move from an empirical approach to a targeted preventive or curative approach (monoclonal antibodies, vaccines, anti-viral drugs).
Nirsevimab is a monoclonal antibody against RSV with enhanced neutralising activity and a prolonged half-life. A randomised, placebo-controlled phase III trial demonstrated the effectiveness of nirsevimab in reducing lower respiratory tract infections caused by RSV requiring medical management in healthy premature and term infants, with a favourable safety profile. The US Food and Drug Administration (FDA) approved the first RSV vaccine on May 3, 2023, and the second was approved on May 31, 2023. Nirsevimab was approved by the European Medicines Agency (EMA) on November 4, 2022.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children under 12 months of age
- •Treated for acute RSV bronchiolitis
- •Hospitalised following a visit to the paediatric emergency department
- •Children under 12 months
- •Hospitalised in the conventional sector or in a short-stay hospital unit, or having consulted a paediatric emergency department for one of the following reasons
- •Febrile urinary tract infection, without acute ear, nose, and throat (ENT) or respiratory symptoms
- •Acute gastroenteritis, without acute ENT or respiratory symptoms
- •Infant colic without fever, without ENT or acute respiratory symptoms
- •Stagnant weight or feeding difficulties without fever, acute ENT or respiratory symptoms
- •Neonatal jaundice without fever or acute ENT or respiratory symptoms
- •Unexplained crying without fever, without ENT or acute respiratory symptoms
- •Head injury, without acute ENT or respiratory symptoms
- •Patient hospitalised for acute surgery without fever, without ENT or acute respiratory symptoms
排除标准
- •Refusal to participate by the patient, their relative or legal representative
- •Administration of Palivizumab.
- •Maternal vaccination against RSV.
结局指标
主要结局
Proportion of patients passively immunised with nirsevimab
时间窗: 7 days
Proportion of patients passively immunised with nirsevimab in children hospitalised with RSV bronchiolitis and in the control group
次要结局
- Length of hospital stay(7 days)
- Proportion of children hospitalised for RSV bronchiolitis with viral co-detection(7 days)
- Proportion of hospitalised children for RSV bronchiolitis requiring invasive or non-invasive ventilatory passively immunised with nirsevimab(7 days)
- Time immunisation(7 days)
- Frequency of hospital admissions(7 days)