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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01754428
First received: December 7, 2012
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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


Condition
Respiratory Syncytial Virus Infections

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Determine the percentage of medically attended Respiratory Syncytial Virus- positive subjects hospitalized for Respiratory Syncytial Virus related symptoms [ Time Frame: Up to seven months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Nasal swabs


Enrollment: 2432
Study Start Date: November 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754428

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

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01754428     History of Changes
Other Study ID Numbers: GS-US-218-0111
Study First Received: December 7, 2012
Last Updated: August 19, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 01, 2014