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

NCT01297504 | Completed Results

• 1 other identifier: P10-129
• Study Type: observational
• Target: 464
• Locations: 7 countries
• Sites: 24

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.

Conditions

Respiratory Syncytial Virus Infection

Keywords

palivizumab; lower respiratory tract infection; Respiratory syncytial virus; usage patterns

Outcome Measures

Primary Outcomes (2)

• 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

• Distribution of Comorbidities in Study Participants

  The percentage of participants with each and combinations of the three comorbidities for which palivizumab is indicated.

  Baseline

Secondary Outcomes (5)

• Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV

  12 months

• Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV

  12 months

• Risk Factors for Hospitalization

  Baseline and 12 months

• Compliance to Prescribed Palivizumab

  12 months

• Mean Number of Doses of Palivizumab Administered

  12 months

Study Arms (1)

Palivizumab

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

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Children excluded from receiving palivizumab as per local guidelines

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Fundasamin (Argentina): collaborator

Study Sites (24)

Site Reference ID/Investigator# 52185

Buenos Aires, C1115AAB, Argentina

Location

Site Reference ID/Investigator# 52182

Buenos Aires, Argentina

Location

Site Reference ID/Investigator# 52183

Buenos Aires, Argentina

Location

Site Reference ID/Investigator# 52184

Buenos Aires, Argentina

Location

Site Reference ID/Investigator# 54426

Santiago, Chile

Location

Site Reference ID/Investigator# 54427

Santiago, Chile

Location

Site Reference ID/Investigator# 52732

Armenia, Colombia

Location

Site Reference ID/Investigator# 52722

Barranquilla, Colombia

Location

Site Reference ID/Investigator# 52726

Barranquilla, Colombia

Location

Site Reference ID/Investigator# 52723

Bogotá, Colombia

Location

Site Reference ID/Investigator# 52725

Bogotá, Colombia

Location

Site Reference ID/Investigator# 52727

Bogotá, Colombia

Location

Site Reference ID/Investigator# 52729

Bogotá, Colombia

Location

Site Reference ID/Investigator# 63882

Bogotá, Colombia

Location

Site Reference ID/Investigator# 52735

Cali, Colombia

Location

Site Reference ID/Investigator# 52731

Medellín, Colombia

Location

Site Reference ID/Investigator# 52703

Quito, Ecuador

Location

Site Reference ID/Investigator# 52704

Quito, Ecuador

Location

Site Reference ID/Investigator# 52082

Guanajuato, Leon, CP 03700, Mexico

Location

Site Reference ID/Investigator# 52084

Mexico City, DF, CP 04530, Mexico

Location

Site Reference ID/Investigator# 52083

Nuevo Leon, Monterrey, CP 66480, Mexico

Location

Site Reference ID/Investigator# 52243

Callao, CALLAO 2, Peru

Location

Site Reference ID/Investigator# 52242

Lima, 33, Peru

Location

Site Reference ID/Investigator# 52246

Salto, Uruguay

Location

Related Links

• Related Info

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Leandro Castillo, MD

  Abbvie S.A.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: February 16, 2011
• Study Start: February 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 1, 2014
• Results First Posted: September 3, 2014

Record last verified: 2014-09

Locations

AR (4); EC (2); CL (2); ME (3); UR (1); PE (2); CO (10)