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Effectiveness of Synagis (Palivizumab) Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus (RSV) Infection

2014-08-27 03:14:27 | BioPortfolio

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)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:27-0400

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