Evaluating the effectiveness of nirsevimab for preventing RSV in infants in Chile
Effectiveness And Impact of Nirsevimab In A Nationwide Immunization Program During The 2024 Winter Campaign In Chile (Nirse-CL)
This study is testing if the medicine nirsevimab can help prevent RSV infections in infants in Chile during the 2024 RSV season.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160000 (estimated) |
| Ages | N/A to 4 Years |
| Sex | All |
| Sponsor | Instituto Sistemas Complejos de Ingeniería Academic / other |
| Drugs / interventions | nirsevimab |
| Locations | 1 site (Santiago) |
| Trial ID | NCT06511687 on ClinicalTrials.gov |
What this trial studies
The Nirse-CL initiative aims to assess the effectiveness of the monoclonal antibody nirsevimab in preventing Respiratory Syncytial Virus (RSV) infections among infants during the 2024 RSV season in Chile. This observational study will analyze data from various national databases before, during, and after the implementation of a universal immunization program. The study targets approximately 160,000 infants, including newborns and high-risk groups, to evaluate the impact of nirsevimab on RSV-related health outcomes at a national level.
Who should consider this trial
Good fit: Ideal candidates include infants born between October 1st, 2023, and September 31st, 2024, particularly those with specific high-risk conditions.
Not a fit: Patients who are not part of the specified age range or do not meet the high-risk criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce RSV-related hospitalizations and improve health outcomes for infants in Chile.
How similar studies have performed: Previous studies on monoclonal antibodies for RSV have shown promise, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects born between October 1st, 2023, to September 31st, 2024. * Subjects born with 29 weeks of gestational age (wga) or less who were born between July 1st, 2023 and October 1st, 2023 * Subjects born with Bronchopulmonary Dysplasia (BPD), 32 or less wga and/or a birth weight less than 1·5 kgs born between April 1st, 2023 and October 1st, 2023. Exclusion Criteria: * No specific criteria has been reported
Where this trial is running
Santiago
- Isci — Santiago, Chile (Recruiting)
Study contacts
- Study coordinator: Leonardo Basso, PhD in Business Administration
- Email: l.basso@isci.cl
- Phone: 56 962295601
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.