NCT06511687 Effectiveness And Impact Of Nirsevimab In Chile (NIRSE-CL)
| NCT ID | NCT06511687 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto Sistemas Complejos de Ingeniería |
| Condition | RSV |
| Study Type | OBSERVATIONAL |
| Enrollment | 160,000 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2024-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 160,000 participants in total. It began in 2024-04-01 with a primary completion date of 2024-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The Nirse-CL study is a collaborative effort between the Ministry of Health of Chile, Instituto Sistemas Complejos de Ingeniería (ISCI), and the Faculty of Medicine of the University of Chile. The primary aim is to determine the effectiveness of the monoclonal antibody nirsevimab in preventing RSV infection in infants based on the integrated analysis of several national databases before, during, and after the implementation of a universal immunization program. The impact of the program on RSV-related health outcomes will also be determined.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06511687 clinical trial?
This trial is open to participants of all sexes, up to 4 Years, studying RSV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06511687 currently recruiting?
Yes, NCT06511687 is actively recruiting participants. Contact the research team at l.basso@isci.cl for enrollment information.
Where is the NCT06511687 trial being conducted?
This trial is being conducted at Santiago, Chile.
Who is sponsoring the NCT06511687 clinical trial?
NCT06511687 is sponsored by Instituto Sistemas Complejos de Ingeniería. The trial plans to enroll 160,000 participants.