Surveillance Study of Respiratory Syncytial Virus Infection (RSV) in Subjects < 24 Months of Age
A Multi-Center, Outpatient, Surveillance Study of Respiratory Syncytial Virus (RSV) Infection and Respiratory Syncytial Virus-related Hospitalizations Among Subjects < 24 Months of Age With a Medically Attended Respiratory Tract Infection
1 other identifier
observational
2,432
1 country
15
Brief Summary
The purpose of this study is to collect clinical outcome and nasal viral load information.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2012
Shorter than P25 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 7, 2012
CompletedFirst Posted
Study publicly available on registry
December 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedAugust 20, 2013
August 1, 2013
6 months
December 7, 2012
August 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the percentage of medically attended Respiratory Syncytial Virus- positive subjects hospitalized for Respiratory Syncytial Virus related symptoms
Up to seven months
Secondary Outcomes (1)
Percentage of Respiratory Syncytial Virus-positive subjects who sought medical attention, as a result of the Respiratory Tract Infection, after Visit 1
Up to seven months
Eligibility Criteria
Outpatient pediatric clinics, urgent care facilities or emergency departments
You may qualify if:
- \< 24 months of age
- ≥ 35 weeks gestational age at birth
- Signs of acute Respiratory Tract Infection \< 5 days
- Ability to contact parent or legal guardian for follow up
You may not qualify if:
- Ongoing Respiratory Tract Infection
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (15)
University of Alabama at Birmingham
Birmingham, Alabama, 35223, United States
Arkansas Children's Hospital/University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202, United States
University of Colorado Denver/Children's Hospital Colorado
Denver, Colorado, 80045, United States
Pediatrics & Adolescent Medicine, P.A.
Marietta, Georgia, 30062, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004, United States
Children's Mercy Hospital & Clinics
Kansas City, Missouri, 64108, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital, The Ohio State University College of Medicine
Columbus, Ohio, 43205, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
University of Tennessee
Memphis, Tennessee, 38103, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902, United States
Advanced Pediatrics
Vienna, Virginia, 22180, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Biospecimen
Nasal swabs
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John DeVincenzo, MD
University of Tennessee
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2012
First Posted
December 21, 2012
Study Start
November 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
August 20, 2013
Record last verified: 2013-08