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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 12
SponsorMeyer Children's Hospital IRCCS

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Parental refusal

Previous immunization with Palivizumab

Previous maternal RSV vaccine immunization during pregnancy

Trial population

Infants \< 12 months during RSV 2024-2025 epidemic season

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Nirsevimab

    Drug

    Evaluation of drug exposure in cases and controls

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: Cases1 intervention
Group B: Controls1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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