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

This study has been completed.
Sponsor:
Collaborator:
Fundasamin (Argentina)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01297504
First received: February 15, 2011
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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
Respiratory Syncytial Virus Infection

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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: 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.

  • 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 ]

Enrollment: 464
Study Start Date: February 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Palivizumab
Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.

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.

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01297504

Locations
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, Argentina, C1115AAB
Chile
Site Reference ID/Investigator# 54426
Santiago, Chile
Site Reference ID/Investigator# 54427
Santiago, Chile
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# 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# 52723
Bogota, Colombia
Site Reference ID/Investigator# 52735
Cali, Colombia
Site Reference ID/Investigator# 52731
Medellin, Colombia
Ecuador
Site Reference ID/Investigator# 52703
Quito, Ecuador
Site Reference ID/Investigator# 52704
Quito, Ecuador
Mexico
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
Peru
Site Reference ID/Investigator# 52243
Callao, Peru, CALLAO 2
Site Reference ID/Investigator# 52242
Lima, Peru, 33
Uruguay
Site Reference ID/Investigator# 52246
Salto, Uruguay
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Fundasamin (Argentina)
Investigators
Study Director: Leandro Castillo, MD Abbvie S.A.
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01297504     History of Changes
Other Study ID Numbers: P10-129
Study First Received: February 15, 2011
Results First Received: August 22, 2014
Last Updated: August 22, 2014
Health Authority: Uruguay: Comite de Etica
Colombia: Institutional Review Board
Peru: Ethics Committee
Mexico: Federal Commission for Protection Against Health Risks
Ecuador: Public Health Ministry
Argentina: Human Research Bioethics Committee
Chile: Institutional Review Board

Keywords provided by AbbVie:
palivizumab
lower respiratory tract infection
Respiratory syncytial virus
usage patterns

Additional relevant MeSH terms:
Infection
Communicable Diseases
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Palivizumab
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014