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A One-Year Observation of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America

NCT ID: NCT01297504

Last Updated: 2014-10-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

464 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-08-31

Brief Summary

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The study was designed to gather information regarding the use of palivizumab for the prophylaxis for respiratory syncytial virus (RSV) infection in high-risk infants in selected countries within Latin America.

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Detailed Description

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RSV causes significant disease. There is a paucity of data from developing countries even though existing data clearly indicate that RSV accounts for a high proportion of acute respiratory illnesses (ARIs) in children.

This is a multi-center study in a cohort of infants at risk for RSV infection in Latin America who have received palivizumab in the usual manner in accordance with the terms of marketing authorization with regard to dose, population and indication. Enrolled participants were followed for one year after their first dose of palivizumab. Epidemiological and clinical data as well as information about compliance, hospitalizations and safety was collected.

Conditions

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Respiratory Syncytial Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Palivizumab

Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Children with a history of bronchopulmonary dysplasia, infants with a history of prematurity (less than or equal to 35 weeks gestational age), or children with hemodynamically significant congenital heart disease who received the first dose of palivizumab within the 2 weeks prior to the signature of the Informed Consent Form.
* Parent or legal guardian of child provides written Informed Consent

Exclusion Criteria

* Children excluded from receiving palivizumab as per local guidelines
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundasamin (Argentina)

UNKNOWN

Sponsor Role collaborator

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leandro Castillo, MD

Role: STUDY_DIRECTOR

Abbvie S.A.

Locations

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Site Reference ID/Investigator# 52185

Buenos Aires, , Argentina

Site Status

Site Reference ID/Investigator# 52182

Buenos Aires, , Argentina

Site Status

Site Reference ID/Investigator# 52183

Buenos Aires, , Argentina

Site Status

Site Reference ID/Investigator# 52184

Buenos Aires, , Argentina

Site Status

Site Reference ID/Investigator# 54426

Santiago, , Chile

Site Status

Site Reference ID/Investigator# 54427

Santiago, , Chile

Site Status

Site Reference ID/Investigator# 52732

Armenia, , Colombia

Site Status

Site Reference ID/Investigator# 52722

Barranquilla, , Colombia

Site Status

Site Reference ID/Investigator# 52726

Barranquilla, , Colombia

Site Status

Site Reference ID/Investigator# 52723

Bogotá, , Colombia

Site Status

Site Reference ID/Investigator# 52725

Bogotá, , Colombia

Site Status

Site Reference ID/Investigator# 52727

Bogotá, , Colombia

Site Status

Site Reference ID/Investigator# 52729

Bogotá, , Colombia

Site Status

Site Reference ID/Investigator# 63882

Bogotá, , Colombia

Site Status

Site Reference ID/Investigator# 52735

Cali, , Colombia

Site Status

Site Reference ID/Investigator# 52731

Medellín, , Colombia

Site Status

Site Reference ID/Investigator# 52703

Quito, , Ecuador

Site Status

Site Reference ID/Investigator# 52704

Quito, , Ecuador

Site Status

Site Reference ID/Investigator# 52082

Guanajuato, Leon, , Mexico

Site Status

Site Reference ID/Investigator# 52084

Mexico City, DF, , Mexico

Site Status

Site Reference ID/Investigator# 52083

Nuevo Leon, Monterrey, , Mexico

Site Status

Site Reference ID/Investigator# 52243

Callao, , Peru

Site Status

Site Reference ID/Investigator# 52242

Lima, , Peru

Site Status

Site Reference ID/Investigator# 52246

Salto, , Uruguay

Site Status

Countries

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Argentina Chile Colombia Ecuador Mexico Peru Uruguay

Related Links

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http://dailymed.nlm.nih.gov/dailymed/about.cfm

Related Info

Other Identifiers

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P10-129

Identifier Type: -

Identifier Source: org_study_id

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