Actively Recruiting
Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.
Led by Meyer Children's Hospital IRCCS · Updated on 2025-03-10
138
Participants Needed
8
Research Sites
16 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age less than 12 months
- Diagnosis of lower respiratory tract infection (bronchiolitis and/or pneumonia) at admission (case patients)
- Positive RSV PCR on nasopharyngeal swab (case patients)
- Age less than 12 months (control patients)
- Diagnosis of lower respiratory tract infection (bronchiolitis and/or pneumonia) at admission (control patients)
- Hospitalized for conditions other than respiratory infections (control patients)
You will not qualify if you...
- Parental refusal to participate
- Previous immunization with Palivizumab
- Previous maternal RSV vaccine immunization during pregnancy
AI-Screening
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Trial Site Locations
Total: 8 locations
1
SOC Pediatria Ospedale San Donato
Arezzo, Arezzo, Italy, 52100
Actively Recruiting
2
SOC Pediatria Ospedale Santa Maria Annunziata
Bagno a Ripoli, Firenze, Italy, 50012
Actively Recruiting
3
SOC Neonatologia e Terapia Intensiva Neonatale, Ospedale San Giovanni Di Dio
Florence, Firenze, Italy, 50134
Actively Recruiting
4
Meyer Children's Hospital IRCCS
Florence, Italy, Italy, 50139
Actively Recruiting
5
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, Italy, 56123
Actively Recruiting
6
SOC Pediatria e Neonatologia Ospedale San Jacopo
Pistoia, Pistoia, Italy, 51100
Actively Recruiting
7
SOC Pediatria e Neonatologia Ospedale Santo Stefano
Prato, Prato, Italy, 59100
Actively Recruiting
8
SOC Pediatria AOU Senese
Siena, Siena, Italy, 53100
Actively Recruiting
Research Team
G
Giuseppe Indolfi
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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