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

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ClinicalTrials.gov Identifier: NCT01297504
Recruitment Status : Completed
First Posted : February 16, 2011
Results First Posted : September 3, 2014
Last Update Posted : October 1, 2014
Sponsor:
Collaborator:
Fundasamin (Argentina)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Description
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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.

Condition or disease
Respiratory Syncytial Virus Infection

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 Design
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Study Type : Observational
Actual Enrollment : 464 participants
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
Study Start Date : February 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Palivizumab

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


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV [ Time Frame: 12 months ]
  3. 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.

  4. 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.

  5. Mean Number of Doses of Palivizumab Administered [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study was conducted at primary care clinics in Latin America.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297504


Locations
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Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Fundasamin (Argentina)
Investigators
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Study Director: Leandro Castillo, MD Abbvie S.A.
More Information
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Additional Information:

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Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01297504    
Other Study ID Numbers: P10-129
First Posted: February 16, 2011    Key Record Dates
Results First Posted: September 3, 2014
Last Update Posted: October 1, 2014
Last Verified: September 2014
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
palivizumab
lower respiratory tract infection
Respiratory syncytial virus
usage patterns
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Virus Diseases
Respiratory Syncytial Virus Infections
Disease Attributes
 Pathologic Processes
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections