Evaluating Nirsevimab's effect on RSV hospitalizations in infants
Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age: A Case-Control Study
Meyer Children's Hospital IRCCS · NCT06856967
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 |
|---|---|
| Enrollment | 138 (estimated) |
| Ages | N/A to 12 Months |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS (other) |
| Drugs / interventions | Palivizumab, Nirsevimab |
| Locations | 8 sites (Arezzo, Arezzo and 7 other locations) |
| Trial ID | NCT06856967 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under 12 months old diagnosed with lower respiratory tract infections and confirmed RSV infections.
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.
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 performed: Other studies have shown promising results with monoclonal antibodies for RSV prevention, indicating potential success for this approach.
Eligibility criteria
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 this trial is running
Arezzo, Arezzo and 7 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Respiratory Synctial Virus Infections