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Clinical Trials in Italy / NCT06856967
Recruiting Observational

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

NCT06856967 · tracked via the Priya Life Science Italy tracker
Sponsor
Meyer Children's Hospital IRCCS
Phase
Observational
Started
2024-12-04
Last updated
2025-03-10

Condition(s) studied

Respiratory Synctial Virus Infections

Investigational drug(s) / intervention(s)

Nirsevimab →

Nirsevimab: Evaluation of drug exposure in cases and controls

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
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

Primary outcome measure(s)

  • The proportion of patients immunized with Nirsevimab among children hospitalized for RSV-related LRTI and those in the control group. — November 2024-March 2025

Trial sites (8)

FacilityCityRegionStatus
SOC Pediatria Ospedale San Donato Arezzo Arezzo Recruiting
SOC Pediatria Ospedale Santa Maria Annunziata Bagno a Ripoli Firenze Recruiting
SOC Neonatologia e Terapia Intensiva Neonatale, Ospedale San Giovanni Di Dio Florence Firenze Recruiting
Meyer Children's Hospital IRCCS Florence Italy Recruiting
Azienda Ospedaliero Universitaria Pisana Pisa Italy Recruiting
SOC Pediatria e Neonatologia Ospedale San Jacopo Pistoia Pistoia Recruiting
SOC Pediatria e Neonatologia Ospedale Santo Stefano Prato Prato Recruiting
SOC Pediatria AOU Senese Siena Siena Recruiting

On this site

📄 Beyfortus (nirsevimab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06856967 on ClinicalTrials.gov ↗ ← All trials in Italy