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

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

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 2432

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Outpatient pediatric clinics, urgent care facilities or emergency departments

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine the percentage of medically attended Respiratory Syncytial Virus- positive subjects hospitalized for Respiratory Syncytial Virus related symptoms	Up to seven months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Principal Investigator: John DeVincenzo, MD, University of Tennessee

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: December 7, 2012
• First Submitted That Met QC Criteria: December 20, 2012
• First Posted (Estimate): December 21, 2012

Study Record Updates

• Last Update Posted (Estimate): August 20, 2013
• Last Update Submitted That Met QC Criteria: August 19, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: RSV; Virus; Respiratory; Syncytial
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Disease Attributes; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Infections; Communicable Diseases; Virus Diseases; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: GS-US-218-0111