Sinusitis in Children and the Nasopharyngeal Microbiome

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01492868
First received: December 13, 2011
Last updated: May 10, 2016
Last verified: May 2016
  Purpose
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
Sinusitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sinusitis in Children and the Nasopharyngeal Microbiome

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Define relationships between the nasopharyngeal microbiome, viral illnesses, and progression to clinical sinusitis. [ Time Frame: Over a 1 year time frame ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
Nasopharyngeal microbiome samples

Estimated Enrollment: 355
Study Start Date: January 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   4 Years to 7 Years   (Child)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01492868     History of Changes
Other Study ID Numbers: GRANT 10785179  1R01AI097172-01 
Study First Received: December 13, 2011
Last Updated: May 10, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 23, 2016