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OpenTrials
Completed

NCT Number: NCT01492868

Sinusitis in Children and the Nasopharyngeal Microbiome

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.

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Key information

Conditions

Sinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UW Health West Towne Pediatrics, Madison, Wisconsin, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Define relationships between the nasopharyngeal microbiome, viral illnesses, and progression to clinical sinusitis.

    Time frame: Over a 1 year time frame

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Dec 15, 2011
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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