Surveillance Study of Respiratory Syncytial Virus Infection (RSV) in Subjects < 24 Months of Age
NCT ID: NCT01754428
Last Updated: 2013-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2432 participants
OBSERVATIONAL
2012-11-30
2013-05-31
Brief Summary
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Detailed Description
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The availability of a novel anti-Respiratory Syncytial Virus therapeutic that reduces the number of hospitalizations related to Respiratory Syncytial Virus infection would fulfill an unmet medical need in the pediatric population. For maximum effect, such a treatment should be administered as early as possible in the course of infection. Accordingly, the opportunities for early intervention with an anti-Respiratory Syncytial Virus therapeutic are in the outpatient setting, prior to hospitalization. However, the incidence of Respiratory Syncytial Virus-related hospitalization, as well as the natural history and viral dynamics of Respiratory Syncytial Virus infection, remain undefined in the outpatient setting. A better understanding of the prevalence of Respiratory Syncytial Virus infection and subsequent hospitalization rates among symptomatic infants as well as the early disease course of Respiratory Syncytial Virus infection will help in the design of clinical trials needed to assess the efficacy of an anti-Respiratory Syncytial Virus therapeutic developed by Gilead Sciences.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* ≥ 35 weeks gestational age at birth
* Signs of acute Respiratory Tract Infection \< 5 days
* Ability to contact parent or legal guardian for follow up
Exclusion Criteria
* Lung disease
* Heart disease
* Respiratory Syncytial Virus medication in the last 6 months
* Participation in a study with investigational medicinal product in the last 28 days
24 Months
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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John DeVincenzo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arkansas Children's Hospital/University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of Colorado Denver/Children's Hospital Colorado
Denver, Colorado, United States
Pediatrics & Adolescent Medicine, P.A.
Marietta, Georgia, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States
Children's Mercy Hospital & Clinics
Kansas City, Missouri, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital, The Ohio State University College of Medicine
Columbus, Ohio, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Tennessee
Memphis, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States
Advanced Pediatrics
Vienna, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Other Identifiers
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GS-US-218-0111
Identifier Type: -
Identifier Source: org_study_id