Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains

NCT02968758 | Completed Results FDA Device

• 1 other identifier: GenePOC CDiff_clinical-01
• Study Type: interventional
• Target: 2,461
• Locations: 2 countries
• Sites: 7

Brief Summary

The primary purpose of this clinical investigation is to verify the performance of the GenePOC CDiff test on the GenePOC instrument. This will be achieved by comparing the GenePOC CDiff test to the Toxigenic Culture (TC) and cell cytotoxicity neutralisation assay (CCNA), a conventional method considered as gold standard for detection of toxigenic Clostridium difficile in stool specimens.

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

• Performance Characteristics : Clinical Sensitivity (True Positive Rate) and Clinical Specificity (True Negative Rate) in Comparison to the Reference Method

  To establish the performance characteristics of the GenePOC CDiff System for its use in determining the presence of CDiff in liquid/unformed stool specimen obtained from patients suspected of having C. difficile infection (CDI). Sensitivity will be established as the proportion of positives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method. Specificity will be established as the proportion of negatives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.

  At the time of the results with Reference Method is confirmed, up to 3 months

Secondary Outcomes (3)

• Positive and Negative Predictive Values (PPV and NPV)

  At the time of the results with Reference Method is confirmed, up to 3 months

• Unresolved Sample Results

  At the time of the results with Reference Method is confirmed, up to 3 months

• Indeterminate Sample Results

  At the time of the results with Reference Method is confirmed, up to 3 months

Study Arms (1)

Accuracy Testing

EXPERIMENTAL

Comparison between GenePOC PCR and Reference Method

Device: Comparison between GenePOC PCR and Reference Method

Interventions

Comparison between GenePOC PCR and Reference Method DEVICE

Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.

Accuracy Testing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Unformed Stool specimens from patients suspected of having CDI for whom diagnostic tests are indicated and ordered;
• At least 1.25mL of unformed stool specimen (defined as specimen assuming the shape of its container);
• Only one (1) specimen per patient will be included in the study;
• Materials use within their expiration date;
• Transport, storage times, and conditions (e.g. room temperature and/or refrigerated) within requested indications.

You may not qualify if:

• Specimens from patients for whom CDI diagnostic tests have not been ordered;
• Transport and storage times and conditions that exceed these Study Protocol requirements;
• Formed or hard stool specimens or rectal swabs.

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead

Study Sites (7)

Wishard Health Services

Indianapolis, Indiana, 46202, United States

Location

John Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Detroit Medical Center University Laboratories

Detroit, Michigan, 48201, United States

Location

Tricore Laboratory University of New Mexico

Albuquerque, New Mexico, 87102, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex

Toronto, Ontario, M5G 1X5, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Dr Keith Chiasson, PhD
• Organization: GenePOC

keith.chiasson@genepoc.ca

418-650-3535

Study Officials

• Patrice Allibert

  Meridian Bioscience, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 21, 2016
• Study Start: February 6, 2017
• Primary Completion: August 2, 2017
• Study Completion: August 10, 2017
• Last Updated: May 3, 2021
• Results First Posted: January 11, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (5)