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

Respiratory Syncytial Virus Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754428
• Other study ID #: GS-US-218-0111
• Status: Completed
• Phase: N/A
• First received: December 7, 2012
• Last updated: August 19, 2013
• Start date: November 2012
• Est. completion date: May 2013

Study information

• Verified date: August 2013
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2432
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Syncytial Virus Infections
• Respiratory Tract Infections
• Virus Diseases

Locations

Country	Name	City	State
United States	Kentucky Pediatric/Adult Research	Bardstown	Kentucky
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Pediatric Research of Charlottesville, LLC	Charlottesville	Virginia
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Nationwide Children's Hospital, The Ohio State University College of Medicine	Columbus	Ohio
United States	University of Colorado Denver/Children's Hospital Colorado	Denver	Colorado
United States	Baylor College of Medicine	Houston	Texas
United States	Children's Mercy Hospital & Clinics	Kansas City	Missouri
United States	Arkansas Children's Hospital/University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Pediatrics & Adolescent Medicine, P.A.	Marietta	Georgia
United States	University of Tennessee	Memphis	Tennessee
United States	Vanderbilt University	Nashville	Tennessee
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Seattle Children's Hospital	Seattle	Washington
United States	Advanced Pediatrics	Vienna	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the percentage of medically attended Respiratory Syncytial Virus- positive subjects hospitalized for Respiratory Syncytial Virus related symptoms		Up to seven months	No
Secondary	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	No