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

Launched by MEYER CHILDREN'S HOSPITAL IRCCS · Feb 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Nirsevimab, which is designed to help protect infants under one year old from a viral infection known as Respiratory Syncytial Virus (RSV). The main goal of the study is to see if Nirsevimab can reduce the number of hospital visits for serious respiratory issues caused by RSV during the RSV season of 2024-2025. The research will take place in eight children's hospitals in Tuscany, Italy, where doctors will compare infants who received Nirsevimab with those who did not, while also looking at how this impacts the overall spread of the virus.

To be eligible for this study, infants must be less than 12 months old and have been diagnosed with lower respiratory infections like bronchiolitis or pneumonia. Participants in the study will be carefully monitored to understand how well the medication works and how it affects their recovery. Parents should know that infants who have previously been vaccinated for RSV or whose mothers received the RSV vaccine during pregnancy will not be included in the trial. This study aims to gather important information that could help improve RSV prevention strategies and shape public health policies for the future.

Gender

ALL

Eligibility criteria

• 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