Sinusitis in Children and the Nasopharyngeal Microbiome

May 2, 2018 updated by: University of Wisconsin, Madison

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

323

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • UW Pediatrics at 20 S. Park St
      • Madison, Wisconsin, United States, 53717
        • UW Health West Towne Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy children

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: Over a 1 year time frame
Over a 1 year time frame

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Ellen R Wald, MD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

December 14, 2011

First Posted (Estimate)

December 15, 2011

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0562
  • 1R01AI097172-01 (U.S. NIH Grant/Contract)
  • 2011-0535 (Other Identifier: HS IRB)
  • GRANT 10785179 (Other Identifier: Study Team)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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