Surveillance Study of Respiratory Syncytial Virus Infection (RSV) in Subjects < 24 Months of Age
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ClinicalTrials.gov Identifier: NCT01754428 |
Recruitment Status :
Completed
First Posted : December 21, 2012
Last Update Posted : August 20, 2013
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Condition or disease |
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Respiratory Syncytial Virus Infections |
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 |
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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754428
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 |
Principal Investigator: | John DeVincenzo, MD | University of Tennessee |
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01754428 |
Other Study ID Numbers: |
GS-US-218-0111 |
First Posted: | December 21, 2012 Key Record Dates |
Last Update Posted: | August 20, 2013 |
Last Verified: | August 2013 |
Respiratory Syncytial Virus RSV |
Infection Communicable Diseases Virus Diseases Respiratory Syncytial Virus Infections |
Pneumovirus Infections Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections |