Sinusitis in Children and the Nasopharyngeal Microbiome
Completed
- Conditions
- Sinusitis
- Registration Number
- NCT01492868
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
The purpose of this study is to investigate the relationship between viral infections of the upper respiratory tract, perturbations of the nasopharyngeal microbiome in children, and the risk of acute bacterial sinusitis over a one year period. The investigators will determine the incidence of acute bacterial sinusitis post viral upper respiratory infection and identify the viral antecedent infections and other risk factors which predispose to infection and ultimately design strategies to reduce the burden of disease and antimicrobial resistance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 323
Inclusion Criteria
- Children 4 to 7 years of age
- Healthy
- English-speaking parent/guardian -
Exclusion Criteria
- Any underlying condition which would predispose them to the development of sinusitis including congenital or acquired immunodeficiencies
- Craniofacial abnormalities
- Cystic fibrosis
- Allergic rhinitis or a previous episode of chronic sinusitis.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of acute bacterial sinusitis in children 49 to 84 months of age (which is the peak age incidence of sinusitis) as a complication of an antecedent viral upper respiratory infection. Over a 1 year time frame
- Secondary Outcome Measures
Name Time Method Define relationships between the nasopharyngeal microbiome, viral illnesses, and progression to clinical sinusitis. Over a 1 year time frame
Trial Locations
- Locations (2)
UW Pediatrics at 20 S. Park St
🇺🇸Madison, Wisconsin, United States
UW Health West Towne Pediatrics
🇺🇸Madison, Wisconsin, United States