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
  Purpose

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


Condition
Respiratory Syncytial Virus Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A One-Year Observational Study of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 462
Study Start Date: February 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Infants at Risk for Respiratory Syncytial Virus Infection

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.

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary Care Clinic

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:

- Child excluded from receiving palivizumab as per local practice

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297504

Locations
Argentina
Site Reference ID/Investigator# 52182
Buenos Aires, Argentina
Site Reference ID/Investigator# 52183
Buenos Aires, Argentina
Site Reference ID/Investigator# 52184
Buenos Aires, Argentina
Site Reference ID/Investigator# 52185
Buenos Aires, Argentina, C1115AAB
Chile
Site Reference ID/Investigator# 54426
Santiago, Chile
Colombia
Site Reference ID/Investigator# 52732
Armenia, Colombia
Site Reference ID/Investigator# 52722
Barranquilla, Colombia
Site Reference ID/Investigator# 52726
Barranquilla, Colombia
Site Reference ID/Investigator# 63882
Bogota, Colombia
Site Reference ID/Investigator# 52727
Bogota, Colombia
Site Reference ID/Investigator# 52729
Bogota, Colombia
Site Reference ID/Investigator# 52723
Bogota, Colombia
Site Reference ID/Investigator# 52725
Bogota, Colombia
Site Reference ID/Investigator# 52735
Cali, Colombia
Site Reference ID/Investigator# 52731
Medellin, Colombia
Ecuador
Site Reference ID/Investigator# 52703
Quito, Ecuador
Site Reference ID/Investigator# 52704
Quito, Ecuador
Mexico
Site Reference ID/Investigator# 52082
Guanajuato, Leon, Mexico, CP 03700
Site Reference ID/Investigator# 52084
Mexico City, DF, Mexico, CP 04530
Site Reference ID/Investigator# 52083
Nuevo Leon, Monterrey, Mexico, CP 66480
Peru
Site Reference ID/Investigator# 52243
Callao, Peru, CALLAO 2
Site Reference ID/Investigator# 52242
Lima, Peru, 33
Uruguay
Site Reference ID/Investigator# 52246
Salto, Uruguay
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Fundasamin (Argentina)
Investigators
Study Director: Gonzalo Rubio, MD Abbvie S.A.
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01297504     History of Changes
Other Study ID Numbers: P10-129
Study First Received: February 15, 2011
Last Updated: August 29, 2013
Health Authority: Uruguay: Comite de Etica
Colombia: Institutional Review Board
Peru: Ethics Committee
Mexico: Federal Commission for Protection Against Health Risks
Ecuador: Public Health Ministry
Argentina: Human Research Bioethics Committee
Chile: Institutional Review Board

Keywords provided by AbbVie:
palivizumab
lower respiratory tract infection
Respiratory syncytial virus
usage patterns

Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Palivizumab
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014