Sinusitis in Children and the Nasopharyngeal Microbiome
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ClinicalTrials.gov Identifier: NCT01492868
Recruitment Status :
First Posted : December 15, 2011
Last Update Posted : May 8, 2018
University of Wisconsin, Madison
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
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.
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. [ Time Frame: Over a 1 year time frame ]
Secondary Outcome Measures :
Define relationships between the nasopharyngeal microbiome, viral illnesses, and progression to clinical sinusitis. [ Time Frame: Over a 1 year time frame ]
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Ages Eligible for Study:
4 Years to 7 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Children 4 to 7 years of age
English-speaking parent/guardian -
Any underlying condition which would predispose them to the development of sinusitis including congenital or acquired immunodeficiencies
Allergic rhinitis or a previous episode of chronic sinusitis.