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NCT Number: NCT06856967

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

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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Key information

Conditions

Respiratory Synctial Virus Infections

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

SOC Pediatria Ospedale San Donato, Arezzo, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nirsevimab

Drug

Evaluation of drug exposure in cases and controls

Primary outcomes

  1. The proportion of patients immunized with Nirsevimab among children hospitalized for RSV-related LRTI and those in the control group.

    Time frame: November 2024-March 2025

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Indolfi

CONTACT

[email protected]

+3905556621

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Official study title

Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age: A Case-Control Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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