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Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.
Sponsor: Meyer Children's Hospital IRCCS
Summary
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.
Official title: Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age: A Case-Control Study
Key Details
Gender
All
Age Range
Any - 12 Months
Study Type
OBSERVATIONAL
Enrollment
138
Start Date
2024-12-04
Completion Date
2025-04
Last Updated
2025-03-10
Healthy Volunteers
No
Conditions
Interventions
Nirsevimab
Evaluation of drug exposure in cases and controls
Locations (8)
SOC Pediatria Ospedale San Donato
Arezzo, Arezzo, Italy
SOC Pediatria Ospedale Santa Maria Annunziata
Bagno a Ripoli, Firenze, Italy
SOC Neonatologia e Terapia Intensiva Neonatale, Ospedale San Giovanni Di Dio
Florence, Firenze, Italy
Meyer Children's Hospital IRCCS
Florence, Italy, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, Italy
SOC Pediatria e Neonatologia Ospedale San Jacopo
Pistoia, Pistoia, Italy
SOC Pediatria e Neonatologia Ospedale Santo Stefano
Prato, Prato, Italy
SOC Pediatria AOU Senese
Siena, Siena, Italy