Clinical trial NCT01754428: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory
Syncytial
Virus
RSV
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-12-21
Enrollment: 2432
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatient pediatric clinics, urgent care facilities or emergency departments

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.

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

Primary outcomes:
measure: Determine the percentage of medically attended Respiratory Syncytial Virus- positive subjects hospitalized for Respiratory Syncytial Virus related symptoms
timeFrame: Up to seven months
Secondary outcomes:
measure: Percentage of Respiratory Syncytial Virus-positive subjects who sought medical attention, as a result of the Respiratory Tract Infection, after Visit 1
timeFrame: Up to seven months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Children's Hospital/University of Arkansas for Medical Sciences
state: Arkansas
city: Denver
country: United States
facility: University of Colorado Denver/Children's Hospital Colorado
state: Colorado
city: Marietta
country: United States
facility: Pediatrics & Adolescent Medicine, P.A.
state: Georgia
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Kansas City
country: United States
facility: Children's Mercy Hospital & Clinics
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital, The Ohio State University College of Medicine
state: Ohio
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
city: Vienna
country: United States
facility: Advanced Pediatrics
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: University of Tennessee
name: John DeVincenzo, MD
role: PRINCIPAL_INVESTIGATOR
References: