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

This study has been completed.
Sponsor:
Collaborator:
Fundasamin (Argentina)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01297504
First received: February 15, 2011
Last updated: August 29, 2013
Last verified: August 2013

February 15, 2011
August 29, 2013
February 2011
August 2013   (final data collection date for primary outcome measure)
To describe patterns of palivizumab usage in infants at risk for Respiratory Syncytial Virus (RSV) infection [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Palivizumab has already been prescribed in the usual manner in accordance with the terms of marketing authorization with regard to dose, population and indication.
Same as current
Complete list of historical versions of study NCT01297504 on ClinicalTrials.gov Archive Site
  • To describe Respiratory Syncytial Virus (RSV) hospitalization rates among infants treated with Palivizumab as well as the risk factors potentially associated with hospitalization [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Same as current
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A One-Year Observation of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America
A One-Year Observational Study of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Primary Care Clinic

Respiratory Syncytial Virus Infection
Not Provided
Infants at Risk for Respiratory Syncytial Virus Infection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
462
August 2013
August 2013   (final data collection date for primary outcome measure)

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:

- Child excluded from receiving palivizumab as per local practice

Both
up to 2 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Chile,   Colombia,   Ecuador,   Mexico,   Peru,   Uruguay
 
NCT01297504
P10-129
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Fundasamin (Argentina)
Study Director: Gonzalo Rubio, MD Abbvie S.A.
AbbVie
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP