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

Recruitingn/aAges any - 12 MonthsAllMeyer Children's Hospital IRCCS
NCT06856967 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Nirsevimab
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Where

8 sites
SOC Pediatria Ospedale San Donato
Arezzo, Italy
SOC Pediatria Ospedale Santa Maria Annunziata
Bagno a Ripoli, Italy
SOC Neonatologia e Terapia Intensiva Neonatale, Ospedale San Giovanni Di Dio
Florence, Italy
Meyer Children's Hospital IRCCS
Florence, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
SOC Pediatria e Neonatologia Ospedale San Jacopo
Pistoia, Italy
SOC Pediatria e Neonatologia Ospedale Santo Stefano
Prato, Italy
SOC Pediatria AOU Senese
Siena, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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