Nasal Swab Study to Explore the Nasal Microbia | NCT02535442

Studies
Nasal Swab Study to Explore the Nasal Microbia

NCT02535442

Sponsor

Kimberly-Clark Corporation

Status

Completed

Last Update Posted

Jul 4, 2016Estimated

Enrollment

42Actual

Phase

Not provided

Conditions

Common Cold

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

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

Aug 2015

Primary Completion Date

Apr 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Aug 14, 2015

First Submission Date that Met QC Criteria

Aug 27, 2015

First Posted Date

Aug 28, 2015Estimated

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

Jul 1, 2016

Last Update Posted Date

Jul 4, 2016Estimated

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 objective of this study is to evaluate the microbial consortia and the host inflammatory factors present in the nasal passages of patients during upper respiratory symptomology and when healthy using culture and molecular analysis techniques.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

42Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Type and amount of nasal microbes		Change from baseline compared to Day 21

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults, male or female, between the ages 18 - 60
Exhibiting symptoms of an upper respiratory ailment, which may include runny or stuffy nose, sore throat, fever, headache, cough, malaise, or loss of appetite with no indication or intention to treat with excluded medications.

Exclusion Criteria:

Use of antibiotics, antifungals, antivirals, antihistamines, anticholinergic, anti-inflammatory, any nasal inhaled medications (other than saline), or steroid medications within the four (4) weeks prior to enrollment and during the course of the study. Use of cough suppressants and herbal medications are permitted.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Community sample of male and female subjects with common cold symptoms.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles Fogarty, MD	Spartanburg Medical Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Spartanburg Medical Research		Spartanburg	South Carolina	29303	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19052515	Background	Wolcott RD, Dowd SE. A rapid molecular method for characterising bacterial bioburden in chronic wounds. J Wound Care. 2008 Dec;17(12):513-6. doi: 10.12968/jowc.2008.17.12.31769.
18833331	Background	Dowd SE, Wolcott RD, Sun Y, McKeehan T, Smith E, Rhoads D. Polymicrobial nature of chronic diabetic foot ulcer biofilm infections determined using bacterial tag encoded FLX amplicon pyrosequencing (bTEFAP). PLoS One. 2008 Oct 3;3(10):e3326. doi: 10.1371/journal.pone.0003326.

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010850	Picornaviridae Infections
D012327	RNA Virus Infections