Effectiveness And Impact Of Nirsevimab In Chile (NIRSE-CL)
ConditionRSV
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 4
SponsorInstituto Sistemas Complejos de Ingeniería
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
No specific criteria has been reported
Trial population
All infants born in Chile between October 1st, 2023, to September 31st, 2024 (approximately 160.000), and all high-risk infants born between July 1st, 2023, and October 1st, 2023 (approximately \<1.000).
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Nirsevimab
Biological/VaccineNirsevimab will be administered in a single dose at birth for newborn cohort and at the beginning of the campaign for the other cohorts under study
Treatment groups
160,000 Participants
are divided into 3 treatment groupsGroup A: Newborns1 intervention
Group B: Catch-up1 intervention
Group C: High-risk1 intervention
Trial outcomes
Primary outcomes
1
LRTI
Number and incidence of lower-tract respiratory infections hospitalizations (LRTI) attributed to RSV in the pediatric intensive care units (PICU) at a nationwide and regional level.
Time frame
from April 2024 to October 2024Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov