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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

Tracking Information
First Submitted Date December 13, 2011
First Posted Date December 15, 2011
Last Update Posted Date May 8, 2018
Study Start Date January 2012
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 28, 2015)
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 ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: July 28, 2015)
Define relationships between the nasopharyngeal microbiome, viral illnesses, and progression to clinical sinusitis. [ Time Frame: Over a 1 year time frame ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sinusitis in Children and the Nasopharyngeal Microbiome
Official Title My Nose Study: Sinusitis in Children and How Virus Infections Promote Secondary Bacterial Infections
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Nasopharyngeal microbiome samples
Sampling Method Non-Probability Sample
Study Population Healthy children
Condition Sinusitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 2, 2018)
323
Original Estimated Enrollment
 (submitted: December 14, 2011)
355
Actual Study Completion Date June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 7 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01492868
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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor University of Wisconsin, Madison
Collaborators
  • National Institutes of Health (NIH)
  • National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Ellen R Wald, MD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date May 2018