RECRUITINGOBSERVATIONAL

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: - Parental refusal - Previous immunization with Palivizumab - Previous maternal RSV vaccine immunization during pregnancy Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Nirsevimab

Evaluation of drug exposure in cases and controls

Locations (8)

SOC Pediatria Ospedale San Donato

Arezzo, Arezzo, Italy

SOC Pediatria Ospedale Santa Maria Annunziata

Bagno a Ripoli, Firenze, Italy

SOC Neonatologia e Terapia Intensiva Neonatale, Ospedale San Giovanni Di Dio

Florence, Firenze, Italy

Meyer Children's Hospital IRCCS

Florence, Italy, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy, Italy

SOC Pediatria e Neonatologia Ospedale San Jacopo

Pistoia, Pistoia, Italy

SOC Pediatria e Neonatologia Ospedale Santo Stefano

Prato, Prato, Italy

SOC Pediatria AOU Senese

Siena, Siena, Italy