Sinusitis in Children and the Nasopharyngeal Microbiome

NCT ID: NCT01492868

Last Updated: 2018-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

323 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sinusitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ellen R Wald, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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UW Pediatrics at 20 S. Park St

Madison, Wisconsin, United States

Site Status

UW Health West Towne Pediatrics

Madison, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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http://www.pediatrics.wisc.edu/research/

University of Wisconsin-Madison Department of Pediatrics Research Information

Other Identifiers

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1R01AI097172-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2011-0535

Identifier Type: OTHER

Identifier Source: secondary_id

GRANT 10785179

Identifier Type: OTHER

Identifier Source: secondary_id

2015-0562

Identifier Type: -

Identifier Source: org_study_id

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