In Vitro Diagnostic Device for the Detection of Strep A | NCT02068469

Studies
In Vitro Diagnostic Device for the Detection of Strep A

NCT02068469

Sponsor

IQuum, Inc.

Status

Completed

Last Update Posted

Aug 31, 2016Estimated

Enrollment

799Actual

Phase

Not provided

Conditions

Streptococcal Sore Throat

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

Aug 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

Dec 2013

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Feb 14, 2014

First Submission Date that Met QC Criteria

Feb 20, 2014

First Posted Date

Feb 21, 2014Estimated

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

Aug 30, 2016

Last Update Posted Date

Aug 31, 2016Estimated

Name	Class
Roche Molecular Systems, Inc	INDUSTRY

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 trial is to show the accuracy and specificity of the Liat analyzer and assay for detecting Strep A at the point of care lab compared to culture.

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

799Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate sensitivity and specificity of the Liat Strep A assay when compared to culture		Results based on samples collected at initial visit

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who are 3 years of age or older
Subjects exhibiting symptoms characteristic of pharyngitis, possibly Streptococcus A, including:
- presence of sore throat, and at least one other symptom from the list below:
- redness of the posterior pharyngeal wall
- pharyngeal or tonsillar exudate
- tonsillar swelling
- tender cervical lymphadenopathy
- fever, >38C at presentation or within the past 24 hours
Subjects who are able to understand and consent to participation; for minors under the age of 18, this includes parent or legal guardian

Exclusion Criteria:

Subjects treated with antibiotics currently or within the previous 7 days.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Adult and Pediatric primary care clinic, walk in clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lingjun Chen, BS	IQuum COO	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Norwich Pediatrics		Norwich	Connecticut	06360	United States
Meridian Clinical Research

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided