- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01754428
Surveillance Study of Respiratory Syncytial Virus Infection (RSV) in Subjects < 24 Months of Age
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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35223
- University of Alabama At Birmingham
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72202
- Arkansas Children's Hospital/University of Arkansas for Medical Sciences
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Colorado
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Denver, Colorado, Forenede Stater, 80045
- University of Colorado Denver/Children's Hospital Colorado
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Georgia
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Marietta, Georgia, Forenede Stater, 30062
- Pediatrics & Adolescent Medicine, P.A.
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Kentucky
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Bardstown, Kentucky, Forenede Stater, 40004
- Kentucky Pediatric/Adult Research
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Missouri
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Kansas City, Missouri, Forenede Stater, 64108
- Children's Mercy Hospital & Clinics
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45229
- Cincinnati Children's Hospital Medical Center
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Columbus, Ohio, Forenede Stater, 43205
- Nationwide Children's Hospital, The Ohio State University College of Medicine
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15224
- Children's Hospital of Pittsburgh
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38103
- University of Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University
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Texas
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Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22902
- Pediatric Research of Charlottesville, LLC
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Vienna, Virginia, Forenede Stater, 22180
- Advanced Pediatrics
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Washington
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Seattle, Washington, Forenede Stater, 98105
- Seattle Children's Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Determine the percentage of medically attended Respiratory Syncytial Virus- positive subjects hospitalized for Respiratory Syncytial Virus related symptoms
Tidsramme: Up to seven months
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Up to seven months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Percentage of Respiratory Syncytial Virus-positive subjects who sought medical attention, as a result of the Respiratory Tract Infection, after Visit 1
Tidsramme: Up to seven months
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Up to seven months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: John DeVincenzo, MD, University of Tennessee
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GS-US-218-0111
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