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

Respiratory Syncytial Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297504
• Other study ID #: P10-129
• Status: Completed
• Phase: N/A
• First received: February 15, 2011
• Last updated: September 19, 2014
• Start date: February 2011
• Est. completion date: August 2013

Study information

• Verified date: September 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uruguay: Comite de EticaColombia: Institutional Review BoardPeru: Ethics CommitteeMexico: Federal Commission for Protection Against Health RisksEcuador: Public Health MinistryArgentina: Human Research Bioethics CommitteeChile: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 464
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Syncytial Virus Infection
• Respiratory Syncytial Virus Infections
• Virus Diseases

Locations

Country	Name	City	State
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
Chile	Site Reference ID/Investigator# 54426	Santiago
Chile	Site Reference ID/Investigator# 54427	Santiago
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# 52723	Bogota
Colombia	Site Reference ID/Investigator# 52725	Bogota
Colombia	Site Reference ID/Investigator# 52727	Bogota
Colombia	Site Reference ID/Investigator# 52729	Bogota
Colombia	Site Reference ID/Investigator# 63882	Bogota
Colombia	Site Reference ID/Investigator# 52735	Cali
Colombia	Site Reference ID/Investigator# 52731	Medellin
Ecuador	Site Reference ID/Investigator# 52703	Quito
Ecuador	Site Reference ID/Investigator# 52704	Quito
Mexico	Site Reference ID/Investigator# 52082	Guanajuato, Leon
Mexico	Site Reference ID/Investigator# 52084	Mexico City, DF
Mexico	Site Reference ID/Investigator# 52083	Nuevo Leon, Monterrey
Peru	Site Reference ID/Investigator# 52243	Callao
Peru	Site Reference ID/Investigator# 52242	Lima
Uruguay	Site Reference ID/Investigator# 52246	Salto

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	Fundasamin (Argentina)

Countries where clinical trial is conducted

Argentina,  Chile,  Colombia,  Ecuador,  Mexico,  Peru,  Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection	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).	Baseline	No
Primary	Distribution of Comorbidities in Study Participants	The percentage of participants with each and combinations of the three comorbidities for which palivizumab is indicated.	Baseline	No
Secondary	Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV	The number of participants with hospitalizations due to lower respiratory tract infection (LRTI) and hospitalizations due to lower respiratory tract infection caused by RSV.	12 months	No
Secondary	Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV		12 months	No
Secondary	Risk Factors for Hospitalization	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.	Baseline and 12 months	No
Secondary	Compliance to Prescribed Palivizumab	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.	12 months	No
Secondary	Mean Number of Doses of Palivizumab Administered		12 months	No

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