Evaluating Nirsevimab's effect on RSV hospitalizations in infants
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
Run by Meyer Children's Hospital IRCCS · NCT06856967 · Data updated 2026-11-12
This study is testing if a new antibody called Nirsevimab can help prevent infants under one year old from being hospitalized due to RSV infections.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 12 Months |
| Sex | All |
| Enrollment | 138 (estimated) |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Drugs / interventions | Palivizumab, Nirsevimab |
| Locations | 8 sites (Arezzo, Arezzo and 7 other locations) |
| Status | Recruiting |
| Started | December 4, 2024 |
| Main results expected | March 2025 |
| Study ends | April 2025 |
| Registry record updated | March 10, 2025 |
| Trial ID | NCT06856967 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants under 12 months old diagnosed with lower respiratory tract infections and confirmed RSV infections.
✕Probably not a fit
Patients who may not benefit from this study include those who have previously received immunization with Palivizumab or maternal RSV vaccine immunization during pregnancy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the effectiveness of Nirsevimab, a monoclonal antibody, in reducing hospitalizations due to respiratory syncytial virus (RSV) infections in infants under one year of age. Conducted in Tuscany, Italy, the study will utilize a matched case-control design to evaluate real-world outcomes during the RSV epidemic season of 2024-2025. Additionally, it will analyze the impact of the Nirsevimab immunization campaign on RSV epidemiology, focusing on various patient demographics and clinical outcomes. The goal is to enhance RSV prevention strategies and inform public health policies.
Why it matters
Potential benefit: If successful, this study could significantly reduce RSV-related hospitalizations in infants, improving health outcomes and reducing healthcare costs.
How similar studies have gone: Other studies have shown promising results with monoclonal antibodies for RSV prevention, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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SOC Pediatria Ospedale San Donato
Arezzo, Arezzo, Italy Recruiting -
SOC Pediatria Ospedale Santa Maria Annunziata
Bagno a Ripoli, Firenze, Italy Recruiting -
SOC Neonatologia e Terapia Intensiva Neonatale, Ospedale San Giovanni Di Dio
Florence, Firenze, Italy Recruiting -
Meyer Children's Hospital IRCCS
Florence, Italy, Italy Recruiting -
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, Italy Recruiting -
SOC Pediatria e Neonatologia Ospedale San Jacopo
Pistoia, Pistoia, Italy Recruiting
Show 2 more locations
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SOC Pediatria e Neonatologia Ospedale Santo Stefano
Prato, Prato, Italy Recruiting -
SOC Pediatria AOU Senese
Siena, Siena, Italy Recruiting
Study contacts
- Study coordinator: Giuseppe Indolfi
- Email: giuseppe.indolfi@meyer.it
- Phone: +3905556621
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Preventing RSV in Babies: Nirsevimab with or without maternal RSV vaccine
This study tests whether giving a monoclonal antibody to newborns, with or without the mother’s vaccination during pregnancy, can better protect infants from RSV than giving just one option.
-
Understanding viral infections in infants with bronchiolitis after Nirsevimab use
This study looks at how the use of Nirsevimab affects the types of viral infections in infants under one year old who have their first episode of bronchiolitis.
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Autoimmune podocytopathy and anti-nephrin antibodies
This study tests whether children and adults with nephrotic syndrome have anti-nephrin autoantibodies and whether those antibodies relate to relapses and treatment response.
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Pediatric leishmaniasis in Italy: clinical and treatment patterns
This project will collect medical information to see how leishmaniasis presents and is treated in children under 18 in Italy.
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Infliximab level monitoring in children with inflammatory bowel disease
This project will test whether measuring infliximab levels in saliva and leftover blood during the first infusions helps monitor and personalize treatment for children and teens (ages 3–18) with Crohn's disease or ulcerative colitis.
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Camptodactyly–Arthropathy–Coxa Vara–Pericarditis (CACP) syndrome patient registry and genetic review
This registry collects clinical and genetic information to better understand CACP syndrome in children with confirmed PRG4 mutations.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.