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 22, 2014
Last verified: August 2014

February 15, 2011
August 22, 2014
February 2011
August 2013   (final data collection date for primary outcome measure)
  • Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Study participants were characterized at Baseline by history of bronchopulmonary dysplasia, history of prematurity (less than or equal to 35 weeks gestational age), children with hemodynamically significant congenital heart disease (CHD), the presence of cohabitants less than 6 years old, possible exposure to indoor tobacco smoke, day care attendance, asthmatic or atopic mother, smoking during pregnancy, breastfeeding, prenatal assistance (4 or more visits during pregnancy), neonatal hospitalization care, history of neonatal assisted ventilation, and mother education level (completed primary school).
  • Distribution of Comorbidities in Study Participants [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The percentage of participants with each and combinations of the three comorbidities for which palivizumab is indicated.
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.
Complete list of historical versions of study NCT01297504 on ClinicalTrials.gov Archive Site
  • Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The number of participants with hospitalizations due to lower respiratory tract infection (LRTI) and hospitalizations due to lower respiratory tract infection caused by RSV.
  • Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Risk Factors for Hospitalization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Variables that could act as risk factors for hospitalization for lower respiratory tract infection were tested in univariate and multivariate Poisson regression models. Baseline characteristics, such as age, gender, birth weight and comorbidities were included as covariates in the Poisson regression model. Variables for multivariate analysis were added applying forward selection.
  • Compliance to Prescribed Palivizumab [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Compliance to prescribed palivizumab was calculated based on the number of doses received versus the expected number of doses for each participant. The expected number of doses for each participant was estimated based on seasonality and current prescription guidelines for each country.
  • Mean Number of Doses of Palivizumab Administered [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ]
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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

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.

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.

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

The study was conducted at primary care clinics in Latin America.

Respiratory Syncytial Virus Infection
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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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
464
August 2013
August 2013   (final data collection date for primary outcome measure)

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
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: Leandro Castillo, MD Abbvie S.A.
AbbVie
August 2014

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