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Study identifier: NCT06856967 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Respiratory Synctial Virus Infections  ·  Sponsor: Meyer Children's Hospital IRCCS

PhaseN/A
Planned participants138
Who can joinAll sexes, N/A to 12 Months
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Giuseppe Indolfi  ·  +3905556621  ·  giuseppe.indolfi@meyer.it

Always discuss trial participation with your own doctor first.

Locations (8)

SOC Pediatria Ospedale San DonatoArezzo, Arezzo, ItalyRecruiting
SOC Pediatria Ospedale Santa Maria AnnunziataBagno a Ripoli, Firenze, ItalyRecruiting
SOC Neonatologia e Terapia Intensiva Neonatale, Ospedale San Giovanni Di DioFlorence, Firenze, ItalyRecruiting
Meyer Children's Hospital IRCCSFlorence, Italy, ItalyRecruiting
Azienda Ospedaliero Universitaria PisanaPisa, Italy, ItalyRecruiting
SOC Pediatria e Neonatologia Ospedale San JacopoPistoia, Pistoia, ItalyRecruiting
SOC Pediatria e Neonatologia Ospedale Santo StefanoPrato, Prato, ItalyRecruiting
SOC Pediatria AOU SeneseSiena, Siena, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT06856967