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

Condition(s) targeted: Respiratory Syncytial Virus Infection

Phase: N/A

Status: Recruiting

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Gonzalo Rubio, MD, Study Director, Affiliation: Abbvie S.A.

Overall contact:
Diego Kanevsky, Phone: +54 11 5776 7250, Email: diego.kanevsky@abbvie.com

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

Official title: A One-Year Observational Study of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: To describe patterns of palivizumab usage in infants at risk for Respiratory Syncytial Virus (RSV) infection

Secondary outcome:

To describe Respiratory Syncytial Virus (RSV) hospitalization rates among infants treated with Palivizumab as well as the risk factors potentially associated with hospitalization

To determine compliance rates among of infants prescribed Palivizumab, based on parents adherence to Palivizumab prescription, the physician's pattern of prescription and access to medication

Detailed description: Palivizumab is currently available in 62 countries and a number of studies have been reported in countries othr than the United States (US) and outside the context of the pivotal clinical trials. Nevertheless, there is a paucity of data from developing countries even though, existing data clearly indicate that Respiratory Syncytial Virus (RSV) accounts for a high proportion of Acute Respiratory Illnesses (ARIs) in children.

Minimum age: N/A. Maximum age: 2 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Child received the first dose of Palivizumab within the 2 weeks previous to the signature of the Informed Consent.

2. Parent or legal guardian of child provides written informed consent

Exclusion Criteria:

1. Child excluded from receiving palivizumab as per local practice

Diego Kanevsky, Phone: +54 11 5776 7250, Email: diego.kanevsky@abbvie.com

Site Reference ID/Investigator# 52182, Buenos Aires, Argentina; Recruiting
Site Reference ID/Investigator# 52182, Principal Investigator

Site Reference ID/Investigator# 52183, Buenos Aires, Argentina; Recruiting
Site Reference ID/Investigator# 52183, Principal Investigator

Site Reference ID/Investigator# 52184, Buenos Aires, Argentina; Recruiting
Site Reference ID/Investigator# 52184, Principal Investigator

Site Reference ID/Investigator# 52185, Buenos Aires C1115AAB, Argentina; Recruiting
Site Reference ID/Investigator# 52185, Principal Investigator

Site Reference ID/Investigator# 54426, Santiago, Chile; Recruiting
Site Reference ID/Investigator# 54426, Principal Investigator

Site Reference ID/Investigator# 52732, Armenia, Colombia; Active, not recruiting

Site Reference ID/Investigator# 52722, Barranquilla, Colombia; Completed

Site Reference ID/Investigator# 52726, Barranquilla, Colombia; Active, not recruiting

Site Reference ID/Investigator# 63882, Bogota, Colombia; Active, not recruiting

Site Reference ID/Investigator# 52727, Bogota, Colombia; Active, not recruiting

Site Reference ID/Investigator# 52729, Bogota, Colombia; Active, not recruiting

Site Reference ID/Investigator# 52723, Bogota, Colombia; Active, not recruiting

Site Reference ID/Investigator# 52725, Bogota, Colombia; Active, not recruiting

Site Reference ID/Investigator# 52735, Cali, Colombia; Recruiting
Site Reference ID/Investigator# 52735, Principal Investigator

Site Reference ID/Investigator# 52731, Medellin, Colombia; Recruiting
Site Reference ID/Investigator# 52731, Principal Investigator

Site Reference ID/Investigator# 52704, Quito, Ecuador; Recruiting
Site Reference ID/Investigator# 52704, Principal Investigator

Site Reference ID/Investigator# 52082, Guanajuato, Leon CP 03700, Mexico; Active, not recruiting

Site Reference ID/Investigator# 52084, Mexico City, DF CP 04530, Mexico; Active, not recruiting

Site Reference ID/Investigator# 52083, Nuevo Leon, Monterrey CP 66480, Mexico; Active, not recruiting

Site Reference ID/Investigator# 52243, Callao CALLAO 2, Peru; Recruiting
Site Reference ID/Investigator# 52243, Principal Investigator

Site Reference ID/Investigator# 52242, Lima 33, Peru; Recruiting
Site Reference ID/Investigator# 52242, Principal Investigator

Site Reference ID/Investigator# 52246, Salto, Uruguay; Recruiting
Site Reference ID/Investigator# 52246, Principal Investigator

Starting date: February 2011
Last updated: January 29, 2013