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NCT01492868 Clinical Trial

Sinusitis in Children and the Nasopharyngeal Microbiome

Sinusitis Clinical Trial

Official title:
My Nose Study: Sinusitis in Children and How Virus Infections Promote Secondary Bacterial Infections

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01492868
Other study ID # 2015-0562
Secondary ID 1R01AI097172-012
Status Completed
Phase
First received
Last updated
Start date January 2012
Est. completion date June 2017

Study information
Verified date May 2018
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 323
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 4 Years to 7 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States UW Health West Towne Pediatrics Madison Wisconsin
United States UW Pediatrics at 20 S. Park St Madison Wisconsin

Sponsors (3)
Lead Sponsor Collaborator
University of Wisconsin, Madison National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Define relationships between the nasopharyngeal microbiome, viral illnesses, and progression to clinical sinusitis. Over a 1 year time frame
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