A One-Year Observation 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.
Respiratory Syncytial Virus Infection
|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|
- 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.
- 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: Baseline and 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. 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 ] [ 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 ]
|Study Start Date:||February 2011|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297504
|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|
|Site Reference ID/Investigator# 52182|
|Buenos Aires, Argentina|
|Site Reference ID/Investigator# 54427|
|Site Reference ID/Investigator# 54426|
|Site Reference ID/Investigator# 52732|
|Site Reference ID/Investigator# 52722|
|Site Reference ID/Investigator# 52726|
|Site Reference ID/Investigator# 52725|
|Site Reference ID/Investigator# 52727|
|Site Reference ID/Investigator# 52729|
|Site Reference ID/Investigator# 63882|
|Site Reference ID/Investigator# 52723|
|Site Reference ID/Investigator# 52735|
|Site Reference ID/Investigator# 52731|
|Site Reference ID/Investigator# 52704|
|Site Reference ID/Investigator# 52703|
|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|
|Site Reference ID/Investigator# 52243|
|Callao, Peru, CALLAO 2|
|Site Reference ID/Investigator# 52242|
|Lima, Peru, 33|
|Site Reference ID/Investigator# 52246|
|Study Director:||Leandro Castillo, MD||Abbvie S.A.|