Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.
1 other identifier
observational
138
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2024
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 4, 2024
CompletedFirst Submitted
Initial submission to the registry
February 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedFirst Posted
Study publicly available on registry
March 4, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedMarch 10, 2025
March 1, 2025
3 months
February 26, 2025
March 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of patients immunized with Nirsevimab among children hospitalized for RSV-related LRTI and those in the control group.
November 2024-March 2025
Study Arms (2)
Cases
Patients aged \<1 years hospitalized with confirmed bronchiolitis
Controls
Patients aged \<1 years hospitalized for condition other than confirmed bronchiolitis
Interventions
Eligibility Criteria
Infants \< 12 months during RSV 2024-2025 epidemic season
You may qualify if:
- 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
You may not qualify if:
- Parental refusal
- Previous immunization with Palivizumab
- Previous maternal RSV vaccine immunization during pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
SOC Pediatria Ospedale San Donato
Arezzo, Arezzo, 52100, Italy
SOC Pediatria Ospedale Santa Maria Annunziata
Bagno a Ripoli, Firenze, 50012, Italy
SOC Neonatologia e Terapia Intensiva Neonatale, Ospedale San Giovanni Di Dio
Florence, Firenze, 50134, Italy
Meyer Children's Hospital IRCCS
Florence, Italy, 50139, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56123, Italy
SOC Pediatria e Neonatologia Ospedale San Jacopo
Pistoia, Pistoia, 51100, Italy
SOC Pediatria e Neonatologia Ospedale Santo Stefano
Prato, Prato, 59100, Italy
SOC Pediatria AOU Senese
Siena, Siena, 53100, Italy
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 26, 2025
First Posted
March 4, 2025
Study Start
December 4, 2024
Primary Completion
March 1, 2025
Study Completion
April 1, 2025
Last Updated
March 10, 2025
Record last verified: 2025-03