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

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.

NCT Number	NCT06856967
Lead Sponsor	Meyer Children's Hospital IRCCS
Conditions	Respiratory Synctial Virus Infections
Enrollment	138 participants
Start Date	2024-12-04
Primary Completion	2025-03 (estimated)
Study Completion	2025-04 (estimated)
Updated on ClinicalTrials.gov	2025-03-10