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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Observational Study of the Effectiveness of Synagis Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus Infection

Brief 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 corresponded 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 show that giving five doses of Synagis (palivizumab) resulted in serum concentrations > 30 ug/mL for >20 weeks. 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.

Detailed Summary:
Sponsor: Abbott

Current Primary Outcome: Number of Hospital Admissions by Respiratory Syncytial Virus Infection [ Time Frame: First year of life (up to 12 months) ]

Original Primary Outcome: Number of hospital admissions by Respiratory Syncytial Virus infection per participant [ Time Frame: First year of life (up to 12 months) ]

Current Secondary Outcome:

• Number of Hospital Admission Days (All Causes) [ Time Frame: Hospital admission to hospital discharge ]
  The mean (average) number days participants were hospitalized.
• Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection [ Time Frame: Hospital admission to hospital discharge ]
  The number of days spent in a hospital intensive care unit (ICU) are summarized for those participants requiring that type of care. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.
• Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission [ Time Frame: Hospital admission to hospital discharge ]
  The mean (average) number of days participants required supplemental oxygen during any hospital stay and the mean number of days participants required mechanical ventilation while in the intensive care unit.
• Number of Serious Adverse Events [ Time Frame: Enrollment until 100 days after the last Synagis (palivizumab) dose ]
  The number participants experiencing a serious adverse event. For additional information see the Reported Adverse Events section.

Original Secondary Outcome:

• Number of hospital admission days by Respiratory Syncytial Virus infection [ Time Frame: Hospital discharge ]
• Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection [ Time Frame: Hospital discharge ]
• Number of Ventilation support days during the hospital admission by Respiratory Syncytial Virus infection [ Time Frame: Hospital discharge ]
• Number of Serious Adverse Events [ Time Frame: Enrollment until 100 days after the last Synagis (palivizumab) dose ]

Dates:
Date Received: February 20, 2010
Date Started: September 2007
Date Completion:
Last Updated: October 26, 2012
Last Verified: October 2012