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

Tracking Information

• First Submitted Date: December 7, 2012
• First Posted Date: December 21, 2012
• Last Update Posted Date: August 20, 2013
• Study Start Date: November 2012
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 20, 2012): Determine the percentage of medically attended Respiratory Syncytial Virus- positive subjects hospitalized for Respiratory Syncytial Virus related symptoms [ Time Frame: Up to seven months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: December 20, 2012): 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 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Surveillance Study of Respiratory Syncytial Virus Infection (RSV) in Subjects < 24 Months of Age
• 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
• Brief Summary: The purpose of this study is to collect clinical outcome and nasal viral load information.

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
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

Nasal swabs

• Sampling Method: Probability Sample
• Study Population: Outpatient pediatric clinics, urgent care facilities or emergency departments
• Condition: Respiratory Syncytial Virus Infections
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 19, 2013): 2432
• Original Estimated Enrollment (submitted: December 20, 2012): 4800
• Actual Study Completion Date: May 2013
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 24 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01754428
• Other Study ID Numbers: GS-US-218-0111
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Gilead Sciences
• Study Sponsor: Gilead Sciences
• Collaborators: Not Provided

Investigators

• Principal Investigator: John DeVincenzo, MD; University of Tennessee

• PRS Account: Gilead Sciences
• Verification Date: August 2013