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

Recruiting

• Conditions: Respiratory Synctial Virus Infections
• Interventions: Drug: Nirsevimab

• Registration Number: NCT06856967
• Lead Sponsor: Meyer Children's Hospital IRCCS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-04
• Study First Submitted: 2025-02-26
• Study First Submitted QC: 2025-02-26
• Status Verified: 2025-03
• Primary Completion: 2025-03
• Study First Posted: 2025-03-04
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Nirsevimab	Patients aged \<1 years hospitalized with confirmed bronchiolitis
Controls	Nirsevimab	Patients aged \<1 years hospitalized for condition other than confirmed bronchiolitis

Primary Outcome Measures

Name	Time	Method
The proportion of patients immunized with Nirsevimab among children hospitalized for RSV-related LRTI and those in the control group.	November 2024-March 2025

Trial Locations

Locations (8)

SOC Pediatria Ospedale Santa Maria Annunziata; 🇮🇹 Bagno a Ripoli, Firenze, Italy

SOC Pediatria Ospedale San Donato; 🇮🇹 Arezzo, Italy

SOC Neonatologia e Terapia Intensiva Neonatale, Ospedale San Giovanni Di Dio; 🇮🇹 Firenze, 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