Sinusitis in Children and the Nasopharyngeal Microbiome

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01492868

Enrollment

323

Registered

2011-12-15

Start date

2012-01-31

Completion date

2017-06-30

Last updated

2018-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinusitis

Keywords

sinusitis, upper respiratory infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Years to 7 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results