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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: AbbVie (prior sponsor, Abbott)

Current Primary Outcome:

  • Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection [ Time Frame: Baseline ]
    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 ]
    The percentage of participants with each and combinations of the three comorbidities for which palivizumab is indicated.


Original Primary Outcome: To describe patterns of palivizumab usage in infants at risk for Respiratory Syncytial Virus (RSV) infection [ Time Frame: 48 weeks ]

Palivizumab has already been prescribed in the usual manner in accordance with the terms of marketing authorization with regard to dose, population and indication.


Current Secondary Outcome:

  • Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV [ Time Frame: 12 months ]
    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 ]
  • Risk Factors for Hospitalization [ Time Frame: Baseline and 12 months ]
    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. Gestational age and birth weight were included as continuous variables, considering that the higher they were the better they could act as a protection factor for hospitalization due to respiratory infection.
  • Compliance to Prescribed Palivizumab [ Time Frame: 12 months ]
    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 ]


Original 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 [ Time Frame: 48 weeks ]
  • 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 ]


Information By: AbbVie

Dates:
Date Received: February 15, 2011
Date Started: February 2011
Date Completion:
Last Updated: September 19, 2014
Last Verified: September 2014