Clinical trial NCT01297504: A One-Year Observation of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America
Official title: A One-Year Observational Study of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Syncytial Virus Infection
Keywords: palivizumab
lower respiratory tract infection
Respiratory syncytial virus
usage patterns
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Fundasamin (Argentina)
First posted: 2011-02-16
Enrollment: 464
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was conducted at primary care clinics in Latin America.

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.

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 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

Primary outcomes:
measure: Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection
timeFrame: Baseline
measure: Distribution of Comorbidities in Study Participants
timeFrame: Baseline
Secondary outcomes:
measure: Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV
timeFrame: 12 months
measure: Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV
timeFrame: 12 months
measure: Risk Factors for Hospitalization
timeFrame: Baseline and 12 months
measure: Compliance to Prescribed Palivizumab
timeFrame: 12 months
measure: Mean Number of Doses of Palivizumab Administered
timeFrame: 12 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Site Reference ID/Investigator# 52185
city: Buenos Aires
country: Argentina
facility: Site Reference ID/Investigator# 52182
city: Buenos Aires
country: Argentina
facility: Site Reference ID/Investigator# 52183
city: Buenos Aires
country: Argentina
facility: Site Reference ID/Investigator# 52184
city: Santiago
country: Chile
facility: Site Reference ID/Investigator# 54426
city: Santiago
country: Chile
facility: Site Reference ID/Investigator# 54427
city: Armenia
country: Colombia
facility: Site Reference ID/Investigator# 52732
city: Barranquilla
country: Colombia
facility: Site Reference ID/Investigator# 52722
city: Barranquilla
country: Colombia
facility: Site Reference ID/Investigator# 52726
city: Bogota
country: Colombia
facility: Site Reference ID/Investigator# 52723
city: Bogota
country: Colombia
facility: Site Reference ID/Investigator# 52725
city: Bogota
country: Colombia
facility: Site Reference ID/Investigator# 52727
city: Bogota
country: Colombia
facility: Site Reference ID/Investigator# 52729
city: Bogota
country: Colombia
facility: Site Reference ID/Investigator# 63882
city: Cali
country: Colombia
facility: Site Reference ID/Investigator# 52735
city: Medellin
country: Colombia
facility: Site Reference ID/Investigator# 52731
city: Quito
country: Ecuador
facility: Site Reference ID/Investigator# 52703
city: Quito
country: Ecuador
facility: Site Reference ID/Investigator# 52704
city: Guanajuato, Leon
country: Mexico
facility: Site Reference ID/Investigator# 52082
city: Mexico City, DF
country: Mexico
facility: Site Reference ID/Investigator# 52084
city: Nuevo Leon, Monterrey
country: Mexico
facility: Site Reference ID/Investigator# 52083
city: Callao
country: Peru
facility: Site Reference ID/Investigator# 52243
city: Lima
country: Peru
facility: Site Reference ID/Investigator# 52242
city: Salto
country: Uruguay
facility: Site Reference ID/Investigator# 52246
Study officials:
affiliation: Abbvie S.A.
name: Leandro Castillo, MD
role: STUDY_DIRECTOR
References: