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Sinusitis | Sinusitis in Children and the Nasopharyngeal Microbiome

Sinusitis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Sinusitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Completed

Start Date: January 2012

Completed Date: June 2017

Phase:

Type: Observational

Design:

Primary Outcome: 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.

Secondary Outcome: Define relationships between the nasopharyngeal microbiome, viral illnesses, and progression to clinical sinusitis.

Study sponsors, principal investigator, and references

Principal Investigator: Ellen R Wald, MD

Lead Sponsor: University of Wisconsin, Madison

Collaborator: National Institutes of Health (NIH)

More information:https://clinicaltrials.gov/show/NCT01492868

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