Surveillance Study of Respiratory Syncytial Virus Infection (RSV) in Subjects < 24 Months of Age

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to collect clinical outcome and nasal viral load information.

Condition or disease
Respiratory Syncytial Virus Infections

Detailed Description:

There is no vaccine available to prevent Respiratory Syncytial Virus disease; however, a humanized monoclonal antibody is approved for the prevention of Respiratory Syncytial Virus infection in pediatric patients at high risk of disease (eg, pre-term infants, congenital heart disease, and chronic lung disease). Beyond this high-risk group, infection is common in otherwise healthy infants and can be severe, leading to hospitalization and while uncommon, death. Each year in the United States, approximately 100,000 Respiratory Syncytial Virus-related hospitalizations occur in low risk infants. Currently, treatment of infants suffering from Respiratory Syncytial Virus disease is limited to supportive care with the goal of maintaining adequate oxygenation and nutrition.

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.

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	2432 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	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
Study Start Date :	November 2012
Actual Primary Completion Date :	May 2013
Actual Study Completion Date :	May 2013

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Determine the percentage of medically attended Respiratory Syncytial Virus- positive subjects hospitalized for Respiratory Syncytial Virus related symptoms [ Time Frame: Up to seven months ]

Secondary Outcome Measures :

1. Percentage of Respiratory Syncytial Virus-positive subjects who sought medical attention, as a result of the Respiratory Tract Infection, after Visit 1 [ Time Frame: Up to seven months ]

Biospecimen Retention:   Samples Without DNA

Nasal swabs

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	up to 24 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Outpatient pediatric clinics, urgent care facilities or emergency departments

Criteria

Inclusion Criteria:

• < 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

Exclusion Criteria:

• 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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35223
United States, Arkansas
Arkansas Children's Hospital/University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72202
United States, Colorado
University of Colorado Denver/Children's Hospital Colorado
Denver, Colorado, United States, 80045
United States, Georgia
Pediatrics & Adolescent Medicine, P.A.
Marietta, Georgia, United States, 30062
United States, Kentucky
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States, 40004
United States, Missouri
Children's Mercy Hospital & Clinics
Kansas City, Missouri, United States, 64108
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Nationwide Children's Hospital, The Ohio State University College of Medicine
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States, 38103
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States, 22902
Advanced Pediatrics
Vienna, Virginia, United States, 22180
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105

Sponsors and Collaborators

Gilead Sciences

Investigators

Principal Investigator:	John DeVincenzo, MD	University of Tennessee

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01754428 History of Changes
Other Study ID Numbers:	GS-US-218-0111
First Posted:	December 21, 2012
Last Update Posted:	August 20, 2013
Last Verified:	August 2013

Keywords provided by Gilead Sciences:

Respiratory; Syncytial; Virus; RSV

Additional relevant MeSH terms:

Infection; Communicable Diseases; Virus Diseases; Respiratory Tract Infections; Respiratory Syncytial Virus Infections	Respiratory Tract Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections