Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age: a Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 8
- 主要终点
- The proportion of patients immunized with Nirsevimab among children hospitalized for RSV-related LRTI and those in the control group.
研究概览
简要总结
This study aims to evaluate the impact of Nirsevimab, a monoclonal antibody used for RSV prophylaxis, on reducing RSV- related hospitalizations. It will be conducted at 8 pediatric departments in Tuscany, Italy. First, a matched case-control study investigates the real-world effectiveness of Nirsevimab in preventing RSV-related lower respiratory tract infection (LRTI) hospitalizations during the RSV epidemic season 2024-2025. Second, a descriptive study examines how the Nirsevimab immunization campaign affects RSV epidemiology, focusing on patients' age, comorbidities, infection severity, and clinical outcomes. The findings aim to optimize RSV prevention strategies and inform public health policies.
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 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Case patients
- •Age <12 months
- •Diagnosis of LRTI (i.e., bronchiolitis and/or pneumonia) at admission
- •Positive RSV PCR on nasopharyngeal swab Control patients
- •Age <12 months
- •Diagnosis of LRTI (i.e., bronchiolitis and/or pneumonia) at admission
- •Hospitalized for conditions other than respiratory infections
排除标准
- •Parental refusal
- •Previous immunization with Palivizumab
- •Previous maternal RSV vaccine immunization during pregnancy
研究组 & 干预措施
Cases
Patients aged <1 years hospitalized with confirmed bronchiolitis
干预措施: Nirsevimab (Drug)
Controls
Patients aged <1 years hospitalized for condition other than confirmed bronchiolitis
干预措施: Nirsevimab (Drug)
结局指标
主要结局
The proportion of patients immunized with Nirsevimab among children hospitalized for RSV-related LRTI and those in the control group.
时间窗: November 2024-March 2025
次要结局
未报告次要终点
研究者
Giuseppe Indolfi
MD
Meyer Children's Hospital IRCCS