- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35223
- University of Alabama at Birmingham
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72202
- Arkansas Children's Hospital/University of Arkansas for Medical Sciences
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Colorado
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Denver, Colorado, Estados Unidos, 80045
- University of Colorado Denver/Children's Hospital Colorado
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Georgia
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Marietta, Georgia, Estados Unidos, 30062
- Pediatrics & Adolescent Medicine, P.A.
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Kentucky
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Bardstown, Kentucky, Estados Unidos, 40004
- Kentucky Pediatric/Adult Research
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Missouri
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Kansas City, Missouri, Estados Unidos, 64108
- Children's Mercy Hospital & Clinics
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- Cincinnati Children's Hospital Medical Center
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Columbus, Ohio, Estados Unidos, 43205
- Nationwide Children's Hospital, The Ohio State University College of Medicine
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15224
- Children's Hospital of Pittsburgh
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38103
- University of Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University
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Texas
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Houston, Texas, Estados Unidos, 77030
- Baylor College of Medicine
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22902
- Pediatric Research of Charlottesville, LLC
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Vienna, Virginia, Estados Unidos, 22180
- Advanced Pediatrics
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Washington
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Seattle, Washington, Estados Unidos, 98105
- Seattle Children's Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Determine the percentage of medically attended Respiratory Syncytial Virus- positive subjects hospitalized for Respiratory Syncytial Virus related symptoms
Periodo de tiempo: Up to seven months
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Up to seven months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Percentage of Respiratory Syncytial Virus-positive subjects who sought medical attention, as a result of the Respiratory Tract Infection, after Visit 1
Periodo de tiempo: Up to seven months
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Up to seven months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: John DeVincenzo, MD, University of Tennessee
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GS-US-218-0111
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