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

September 19, 2014 updated by: AbbVie (prior sponsor, Abbott)

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

464

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1115AAB
        • Site Reference ID/Investigator# 52185
      • Buenos Aires, Argentina
        • Site Reference ID/Investigator# 52182
      • Buenos Aires, Argentina
        • Site Reference ID/Investigator# 52183
      • Buenos Aires, Argentina
        • Site Reference ID/Investigator# 52184
  • Chile
      • Santiago, Chile
        • Site Reference ID/Investigator# 54426
      • Santiago, Chile
        • Site Reference ID/Investigator# 54427
  • Colombia
      • Armenia, Colombia
        • Site Reference ID/Investigator# 52732
      • Barranquilla, Colombia
        • Site Reference ID/Investigator# 52722
      • Barranquilla, Colombia
        • Site Reference ID/Investigator# 52726
      • Bogota, 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
      • Cali, Colombia
        • Site Reference ID/Investigator# 52735
      • Medellin, Colombia
        • Site Reference ID/Investigator# 52731
  • Ecuador
      • Quito, Ecuador
        • Site Reference ID/Investigator# 52703
      • Quito, Ecuador
        • Site Reference ID/Investigator# 52704
  • Mexico
      • Guanajuato, Leon, Mexico, CP 03700
        • Site Reference ID/Investigator# 52082
      • Mexico City, DF, Mexico, CP 04530
        • Site Reference ID/Investigator# 52084
      • Nuevo Leon, Monterrey, Mexico, CP 66480
        • Site Reference ID/Investigator# 52083
  • Peru
      • Callao, Peru, CALLAO 2
        • Site Reference ID/Investigator# 52243
      • Lima, Peru, 33
        • Site Reference ID/Investigator# 52242
  • Uruguay
      • Salto, Uruguay
        • Site Reference ID/Investigator# 52246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Palivizumab
Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV
Time Frame: 12 months
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.
Baseline and 12 months
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.
12 months
Mean Number of Doses of Palivizumab Administered
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Collaborators

Fundasamin (Argentina)

Investigators

  • Study Director: Leandro Castillo, MD, Abbvie S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

February 15, 2011

First Submitted That Met QC Criteria

February 15, 2011

First Posted (Estimate)

February 16, 2011

Study Record Updates

Last Update Posted (Estimate)

October 1, 2014

Last Update Submitted That Met QC Criteria

September 19, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P10-129

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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