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

Last updated: March 5, 2025
Sponsor: Meyer Children's Hospital IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Nirsevimab

Clinical Study ID

NCT06856967
RAENHoB
  • Ages < 12
  • All Genders

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 Criteria

Inclusion

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

Exclusion Criteria:

  • Parental refusal

  • Previous immunization with Palivizumab

  • Previous maternal RSV vaccine immunization during pregnancy

Study Design

Total Participants: 138
Treatment Group(s): 1
Primary Treatment: Nirsevimab
Phase:
Study Start date:
December 04, 2024
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • SOC Pediatria Ospedale Santa Maria Annunziata

    Bagno a Ripoli, Firenze 50012
    Italy

    Active - Recruiting

  • SOC Pediatria Ospedale San Donato

    Arezzo, 52100
    Italy

    Active - Recruiting

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

    Firenze, 50134
    Italy

    Active - Recruiting

  • Meyer Children's Hospital IRCCS

    Florence, 50139
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56123
    Italy

    Active - Recruiting

  • SOC Pediatria e Neonatologia Ospedale San Jacopo

    Pistoia, 51100
    Italy

    Active - Recruiting

  • SOC Pediatria e Neonatologia Ospedale Santo Stefano

    Prato, 59100
    Italy

    Active - Recruiting

  • SOC Pediatria AOU Senese

    Siena, 53100
    Italy

    Active - Recruiting

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