Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nirsevimab.
- Who it may be relevant to
- Registry conditions: Respiratory Synctial Virus Infections. Basic parameters: up to 12 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age: A Case-Control Study
Overview
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.
Interventions
- Drug Nirsevimab
Evaluation of drug exposure in cases and controls
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 8 centers
- SOC Pediatria Ospedale San Donato — Arezzo
- SOC Pediatria Ospedale Santa Maria Annunziata — Bagno a Ripoli
- SOC Neonatologia e Terapia Intensiva Neonatale, Ospedale San Giovanni Di Dio — Florence
- Meyer Children's Hospital IRCCS — Florence
- Azienda Ospedaliero Universitaria Pisana — Pisa
- SOC Pediatria e Neonatologia Ospedale San Jacopo — Pistoia
- SOC Pediatria e Neonatologia Ospedale Santo Stefano — Prato
- SOC Pediatria AOU Senese — Siena
Identifiers
NCT: NCT06856967 · RAENHoB