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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 12
SponsorMeyer Children's Hospital IRCCS

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

Qualifiers

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 design

Treatments tested in this trial

  • Nirsevimab

Treatment groups

138 Participants
are divided into 2 treatment groups