NCT03422341

Brief Summary

The primary purpose of this clinical investigation is to establish the performance of the GenePOC Strep A, C/G assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Group A β-hemolytic Streptococcus (GAS) and pyogenic Group C and G β-hemolytic Streptococcus (GCS/GGS) in throat swab samples.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
497

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
2 countries

8 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

January 23, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

February 14, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2018

Completed
Last Updated

May 4, 2021

Status Verified

June 1, 2019

Enrollment Period

5 months

First QC Date

January 23, 2018

Last Update Submit

April 29, 2021

Conditions

Pharyngitis, Infective

Outcome Measures

Primary Outcomes (1)

  • Performance characteristics of the GenePOC Streap A, C/G assay

    To establish the performance characteristics of the GenePOC Strep A, C/G assay for its use in determining the presence of Strep A, C/G in throat swab samples obtained from patients with signs and symptoms of pharyngitis infection. * Sensitivity will be estimated as the proportion of positives that are correctly identified by the GenePOC Strep A, C/G assay when compared to the Reference Method. * Specificity will be established as the proportion of negatives that are correctly identified by the GenePOC Strep A, C/G assay when compared to the Reference Method.

    Up to 14 months

Secondary Outcomes (3)

  • Positive and Negative Predictive Values (PPV and NPV)

    Up to 14 months

  • Unresolved sample results

    Up to 14 months

  • Indeterminate sample results

    Up to 14 months

Study Arms (2)

GenePOC testing

EXPERIMENTAL

The swab will be used for the testing on the revogene using the GenePOC Strep A, C/G assay. Intervention will be the Comparison between GenePOC CR and Reference Method.

Device: Comparison between GenePOC CR and Reference Method

Reference Method

ACTIVE COMPARATOR

The swab will be used to detect the presence or absence of Strep A, C/G using standard microbiology method. Intervention will be the Comparison between GenePOC CR and Reference Method.

Device: Comparison between GenePOC CR and Reference Method

Interventions

Comparison between GenePOC CR and Reference MethodDEVICE

The collected swab will be tested with both the GenePOC Strep A, C/G assay and the Reference Method defined as standard microbiology culture and strain identification using a MALDI TOF.

GenePOC testingReference Method

Eligibility Criteria

Age25 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Samples from patients suspected of having signs and symptoms of a pharyngitis infection
  • Patient that signed the approved Informed Consent Form (if applicable)
  • Patient older than 2 years of age
  • Only one (1) compliant sample per patient is allowed
  • Use of dual swab with either liquid Stuart or liquid Amies transport Medium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Valley Children's Hospital

Madera, California, 93636, United States

Location

Wishard Health Services

Indianapolis, Indiana, 46202, United States

Location

Detroit Medical Center University Laboratories

Detroit, Michigan, 48201, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

BC Children's and Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Mount Sinai Services

Toronto, Ontario, M5G 1Z5, Canada

Location

Centre de Recherche Saint-Louis

Québec, Quebec, G1W 4R4, Canada

Location

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Patrice Allibert

    Meridian Bioscience, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2018

First Posted

February 5, 2018

Study Start

February 14, 2018

Primary Completion

July 11, 2018

Study Completion

July 11, 2018

Last Updated

May 4, 2021

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(5)CA(3)