NCT06856967

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

Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age: A Case-Control Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 138 (estimated)
• Sponsor: Meyer Children's Hospital IRCCS · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Synctial Virus Infections

Interventions

Type	Name	Description
DRUG	Nirsevimab	Evaluation of drug exposure in cases and controls

Timeline

• Start date: 2024-12-04
• Primary completion: 2025-03-01
• Completion: 2025-04-01
• First posted: 2025-03-04
• Last updated: 2025-03-10

Locations

8 sites across 1 country: Italy