Effectiveness of Synagis (Palivizumab) Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus (RSV) Infection
Summary
Published data by the Organización panamericana de la Salud shows that Peru's mortality rate from acute respiratory infections (ARI) in infants less than one year of life is second only to Haiti (14,150/100,000). Government data reports shows a marked increase of RSV infections in Peru. "Instituto Nacional de Salud" (Peru's National Institute of Health) reports between January 1st to February 26th 2006, 62% of their positive samples correspondent to RSV . Epidemiological data from Lima-Peru, demonstrates that there is no specific season for RSV infection although some data suggest an increase in RSV activity during cold months (May to September). (INS data). Clinical studies shows that giving five doses of Synagis(palivizumab) resulted in serum concentrations > 30 ug/mL for >20 weeks, a concentration shown to correlate with protection . The aim of this post-marketing observational study is to determine the RSV hospitalization rate in high-risk infants who received Synagis(palivizumab) through the Social Security Hospitals in the context of routine clinical practice.
Description
.
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Conditions
Respiratory Syncytial Virus Infection
Intervention
Synagis (palivizumab)
Location
Site Reference ID/Investigator# 27834
Arequipa
Peru
2
Status
Active, not recruiting
Source
Abbott
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01107535
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:14:27-0400
Clinical Trials
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Medical and Biotech [MESH] Definitions
Palivizumab
A humanized monoclonal antibody and ANTIVIRAL AGENT that is used to prevent RESPIRATORY SYNCYTIAL VIRUS INFECTIONS in high risk pediatric patients.
Respiratory Syncytial Virus Vaccines
Vaccines or candidate vaccines used to prevent infection with RESPIRATORY SYNCYTIAL VIRUSES.
Respiratory Syncytial Virus, Bovine
A species of PNEUMOVIRUS causing an important respiratory infection in cattle. Symptoms include fever, conjunctivitis, and respiratory distress.
Respiratory Syncytial Virus Infections
Pneumovirus infections caused by the RESPIRATORY SYNCYTIAL VIRUSES. Humans and cattle are most affected but infections in goats and sheep have been reported.
Bronchiolitis, Viral
An acute inflammatory disease of the upper RESPIRATORY TRACT, caused by paramyxoviruses, occurring primarily in infants and young children; the viruses most commonly implicated are PARAINFLUENZA VIRUS TYPE 3; RESPIRATORY SYNCYTIAL VIRUS, HUMAN; and METAPNEUMOVIRUS.
