Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.

Meyer Children's Hospital IRCCS

Status: Enrolling

Conditions: Respiratory Synctial Virus Infections

Treatments: Drug: Nirsevimab

Study type: Observational

Funder types: Other

Identifiers

NCT06856967

RAENHoB

Details and patient eligibility

About

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.

Enrollment: 138 estimated patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Parental refusal
• Previous immunization with Palivizumab
• Previous maternal RSV vaccine immunization during pregnancy

Trial design

138 participants in 2 patient groups

Cases

Description:

Patients aged \<1 years hospitalized with confirmed bronchiolitis

Treatment:

Drug: Nirsevimab

Controls

Description:

Patients aged \<1 years hospitalized for condition other than confirmed bronchiolitis

Treatment:

Drug: Nirsevimab