Sinusitis in Children and the Nasopharyngeal Microbiome | NCT01492868

Studies
Sinusitis in Children and the Nasopharyngeal Microbiome

NCT01492868

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

May 8, 2018Actual

Enrollment

323Actual

Phase

Not provided

Conditions

Sinusitis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R01AI097172-01	U.S. NIH Grant/Contract		View source
2011-0535	Other Identifier	HS IRB
GRANT 10785179	Other Identifier	Study Team

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jun 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Dec 13, 2011

First Submission Date that Met QC Criteria

Dec 14, 2011

First Posted Date

Dec 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2018

Last Update Posted Date

May 8, 2018Actual

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

323Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Define relationships between the nasopharyngeal microbiome, viral illnesses, and progression to clinical sinusitis.		Over a 1 year time frame

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

7 Years

Standard Ages

Child

Study Population

Healthy children

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ellen R Wald, MD	University of Wisconsin, Madison	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UW Pediatrics at 20 S. Park St		Madison	Wisconsin	53715	United States
UW Health West Towne Pediatrics

References Module

Citations

Not provided

ID	Term
D012852	Sinusitis
D012141	Respiratory Tract Infections

ID	Term
D007239	Infections
D010254	Paranasal Sinus Diseases
D009668	Nose Diseases
D012140	Respiratory Tract Diseases