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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014