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

• ClinicalTrials.gov Identifier: NCT01754428
• Recruitment Status: Completed
• First Posted: December 21, 2012
• Last Update Posted: August 20, 2013
• Sponsor: Gilead Sciences
• Information provided by (Responsible Party): Gilead Sciences

Study Description

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

• 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

Outcome Measures

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

• 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

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

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT01754428
• 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 Syncytial Virus Infections; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections