Respiratory Synctial Virus Infections
Conditions
Brief 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.
Interventions
DRUGNirsevimab
Evaluation of drug exposure in cases and controls
Sponsors
Meyer Children's Hospital IRCCS
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients immunized with Nirsevimab among children hospitalized for RSV-related LRTI and those in the control group. | November 2024-March 2025 |
Countries
Italy
Contacts
Primary ContactGiuseppe Indolfi
Outcome results
None listed