NCT01492868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
323

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

5.4 years

First QC Date

December 13, 2011

Last Update Submit

May 2, 2018

Conditions

Sinusitis

Keywords

sinusitisupper respiratory infection

Outcome Measures

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.

    Over a 1 year time frame

Secondary Outcomes (1)

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

    Over a 1 year time frame

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Healthy children

You may qualify if:

  • Children 4 to 7 years of age
  • Healthy
  • English-speaking parent/guardian -

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UW Pediatrics at 20 S. Park St

Madison, Wisconsin, 53715, United States

Location

UW Health West Towne Pediatrics

Madison, Wisconsin, 53717, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal microbiome samples

MeSH Terms

Conditions

SinusitisRespiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Ellen R Wald, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2011

First Posted

December 15, 2011

Study Start

January 1, 2012

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

May 8, 2018

Record last verified: 2018-05

Locations

US(2)