Preview Rapid Strep A Test Method Comparison Study | NCT03907449

Studies
Preview Rapid Strep A Test Method Comparison Study

NCT03907449

Sponsor

Guangzhou Wondfo Biotech Co., Ltd

Status

Suspended

Last Update Posted

Jul 9, 2019Actual

Enrollment

320Estimated

Phase

Not provided

Conditions

Strep Throat

Interventions

Preview Rapid Strep A test

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 2019

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment rates reduced during non-Strep season

Expanded Access Info

Start Date

Mar 19, 2019Actual

Primary Completion Date

May 2020Estimated

Completion Date

May 2020Estimated

First Submitted Date

Apr 5, 2019

First Submission Date that Met QC Criteria

Apr 5, 2019

First Posted Date

Apr 9, 2019Actual

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 6, 2019

Last Update Posted Date

Jul 9, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is designed to determine the accuracy of the Preview Rapid Strep A Test compared to a laboratory reference method for Group A Streptococcal infection and to determine the precision of the Preview Rapid Strep A test.

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

No data available

No data is available for this block.

Enrollment

320Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Symptoms of Strep Throat		Any patient presenting with symptoms of pharyngitis Fever Sore throat Swollen lymph nodes in neck Redness of throat/tonsils White/yellow patches on tonsils Not currently on antibiotics	Diagnostic Test: Preview Rapid Strep A test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preview Rapid Strep A test	Diagnostic Test	Rapid assay for the detection of type A streptococcal infection of the throat.	Symptoms of Strep Throat

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of Preview Strep A Rapid Test	Determination of Positive Predictive Value and Negative Predictive Value for Preview Strep A	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient presenting with symptoms of pharyngitis
- Fever
- Sore throat
- Swollen lymph nodes in neck
- Redness of throat/tonsils
- White/yellow patches on tonsils
- Not currently on antibiotics
≥3 years or older
Ability to read, understand and sign a consent form, in English, or for parent(s) to sign an assent form providing permission to include children under the age of 18.

Exclusion Criteria:

Currently taking antibiotics
Previously enrolled in this study

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

Approximately 320 patients to be tested, expecting 50-100 positive for Strep A collected from patients of any age and gender from two CLIA waived or waivable sites. Children will be enrolled in this study due to the high prevalence of Strep A infections in minors and the intention to market this investigational device for use for all ages following FDA clearance.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul Granato, PhD	UHSH Microbiology	Principal Investigator
Jagmohan Sidhu, MD	UHSH Microbiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UHSH Microbiology		Johnson City	New York	13790	United States
Summerwood Pediatrics

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