This trial is active, not recruiting.

Condition sinusitis
Sponsor University of Wisconsin, Madison
Collaborator National Institutes of Health (NIH)
Start date January 2012
End date June 2017
Trial size 355 participants
Trial identifier NCT01492868, 1R01AI097172-01, GRANT 10785179


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

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 Outcomes

Define relationships between the nasopharyngeal microbiome, viral illnesses, and progression to clinical sinusitis.
time frame: Over a 1 year time frame

Eligibility Criteria

Male or female participants from 4 years up to 7 years old.

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.

Additional Information

Official title Sinusitis in Children and the Nasopharyngeal Microbiome
Principal investigator Ellen R Wald, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.