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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Synctial Virus Infections
• Intervention / Treatment: Drug: Nirsevimab

• Study Type: Observational
• Enrollment (Estimated): 138

Contacts and Locations

• Study Contact: Name: Giuseppe Indolfi; Phone Number: +3905556621; Email: giuseppe.indolfi@meyer.it

Study Locations

• Italy
  • Arezzo, Italy, 52100
    • Recruiting
    • SOC Pediatria Ospedale San Donato
    • Contact: Martini Marco, MD; Phone Number: +390575 255531; Email: marco.martini@uslsudest.toscana.it
  • Firenze, Italy, 50134
    • Recruiting
    • SOC Neonatologia e Terapia Intensiva Neonatale, Ospedale San Giovanni Di Dio
    • Contact: Lori Ilaria, MD; Phone Number: +39055 6932201; Email: ilaria.lori@uslcentro.toscana.it
  • Florence, Italy, 50139
    • Recruiting
    • Meyer Children's Hospital IRCCS
    • Contact: Giuseppe Indolfi
  • Pisa, Italy, 56123
    • Recruiting
    • Azienda Ospedaliero Universitaria Pisana
    • Contact: Diego Peroni
  • Pistoia, Italy, 51100
    • Recruiting
    • SOC Pediatria e Neonatologia Ospedale San Jacopo
    • Contact: Agostiniani RIno, MD; Phone Number: +390573 351122 - 0573 351121; Email: rino1.agostiniani@uslcentro.toscana.it
  • Prato, Italy, 59100
    • Recruiting
    • SOC Pediatria e Neonatologia Ospedale Santo Stefano
    • Contact: Vasarri Pierluigi, MD; Phone Number: +390574802367-2350; Email: pierluigi.vasarri@uslcentro.toscana.it
  • Siena, Italy, 53100
    • Recruiting
    • SOC Pediatria AOU Senese
    • Contact: Grosso Salvatore, Professor, MD; Phone Number: +300577 585292; Email: salvatore.grosso@uslcentro.toscana.it
  • Firenze
    • Bagno a Ripoli, Firenze, Italy, 50012
      • Recruiting
      • SOC Pediatria Ospedale Santa Maria Annunziata
      • Contact: Mirri Gianpaolo, MD; Phone Number: +39055 6936436; Email: gianpaolo.mirri@uslcentro.toscana.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Infants < 12 months during RSV 2024-2025 epidemic season

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; Patients aged <1 years hospitalized with confirmed bronchiolitis	Drug: Nirsevimab; Evaluation of drug exposure in cases and controls
Controls; Patients aged <1 years hospitalized for condition other than confirmed bronchiolitis	Drug: Nirsevimab; Evaluation of drug exposure in cases and controls

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Meyer Children's Hospital IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: February 26, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Infections; Communicable Diseases; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: RAENHoB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No