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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
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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