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Sinusitis in Children and the Nasopharyngeal Microbiome

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ClinicalTrials.gov Identifier: NCT01492868
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease
Sinusitis

Study Type : Observational
Actual Enrollment : 323 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: My Nose Study: Sinusitis in Children and How Virus Infections Promote Secondary Bacterial Infections
Study Start Date : January 2012
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis




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

Biospecimen Retention:   Samples Without DNA
Nasopharyngeal microbiome samples


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Healthy children
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492868


Locations
United States, Wisconsin
UW Pediatrics at 20 S. Park St
Madison, Wisconsin, United States, 53715
UW Health West Towne Pediatrics
Madison, Wisconsin, United States, 53717
Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Ellen R Wald, MD University of Wisconsin, Madison
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:
Study Protocol  [PDF] September 3, 2015


Additional Information:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01492868     History of Changes
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 )
First Posted: December 15, 2011    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Keywords provided by University of Wisconsin, Madison:
sinusitis
upper respiratory infection

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases