About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Parental refusal
Previous immunization with Palivizumab
Previous maternal RSV vaccine immunization during pregnancy
Trial population
Infants \< 12 months during RSV 2024-2025 epidemic season
Trial design
Case-control
Prospective
Treatments tested in this trial
Nirsevimab
DrugEvaluation of drug exposure in cases and controls
Treatment groups
Trial outcomes
Primary outcomes
The proportion of patients immunized with Nirsevimab among children hospitalized for RSV-related LRTI and those in the control group.
Sponsors and contacts
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