A One-Year Observation of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America
This study is ongoing, but not recruiting participants.
Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborator:
Fundasamin (Argentina)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01297504
First received: February 15, 2011
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
A One-Year Observation of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in 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:
MedlinePlus related topics:
Respiratory Syncytial Virus Infections
Drug Information available for:
Palivizumab
U.S. FDA Resources
Further study details as provided by AbbVie:
Primary Outcome Measures:
- To describe patterns of palivizumab usage in infants at risk for Respiratory Syncytial Virus (RSV) infection [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]Palivizumab has already been prescribed in the usual manner in accordance with the terms of marketing authorization with regard to dose, population and indication.
Secondary Outcome Measures:
- To describe Respiratory Syncytial Virus (RSV) hospitalization rates among infants treated with Palivizumab as well as the risk factors potentially associated with hospitalization [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- To determine compliance rates among of infants prescribed Palivizumab, based on parents adherence to Palivizumab prescription, the physician's pattern of prescription and access to medication [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 450 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Infants at Risk for Respiratory Syncytial Virus Infection |
Detailed Description:
Palivizumab is currently available in 62 countries and a number of studies have been reported in countries othr than the United States (US) and outside the context of the pivotal clinical trials. Nevertheless, there is a paucity of data from developing countries even though, existing data clearly indicate that Respiratory Syncytial Virus (RSV) accounts for a high proportion of Acute Respiratory Illnesses (ARIs) in children.
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
Primary Care Clinic
Criteria
Inclusion Criteria:
- Child received the first dose of Palivizumab within the 2 weeks previous to the signature of the Informed Consent.
- Parent or legal guardian of child provides written informed consent
Exclusion Criteria:
1. Child excluded from receiving palivizumab as per local practice
Contacts and Locations
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 | |
| 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# 63882 | |
| Bogota, Colombia | |
| Site Reference ID/Investigator# 52727 | |
| Bogota, Colombia | |
| Site Reference ID/Investigator# 52729 | |
| Bogota, Colombia | |
| Site Reference ID/Investigator# 52723 | |
| Bogota, Colombia | |
| Site Reference ID/Investigator# 52725 | |
| 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: | Gonzalo Rubio, 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 |
| Last Updated: | April 9, 2013 |
| 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:
|
Respiratory Syncytial Virus Infections Virus Diseases 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 June 17, 2013