Actively Recruiting

Age: 0 - 4Years
All Genders
NCT06511687

Effectiveness And Impact Of Nirsevimab In Chile (NIRSE-CL)

Led by Instituto Sistemas Complejos de Ingeniería · Updated on 2024-07-22

160000

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effectiveness And Impact Of Nirsevimab In Chile (NIRSE-CL)

Who Can Participate

Age: 0 - 4Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Born between October 1, 2023, and September 31, 2024
  • Born with 29 weeks of gestational age or less between July 1, 2023, and October 1, 2023
  • Born with Bronchopulmonary Dysplasia (BPD), 32 or less weeks gestational age and/or birth weight less than 1.75 kgs between April 1, 2023, and October 1, 2023
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

ISCI

Santiago, Chile, 8370398

Actively Recruiting

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Research Team

L

Leonardo Basso, PhD in Business Administration

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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