A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients

Completed

• Conditions: Gastroenteritis; Infectious Colitis

• Registration Number: NCT02497417
• Lead Sponsor: Luminex Corporation

Brief Summary

The ARIES C. difficile Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of C. difficile nucleic acid in stool specimens.

Detailed Description

The ARIES C. difficile Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Clostridium difficile (C. difficile) nucleic acid in unformed (liquid or soft) stool specimens obtained from patients suspected of having Clostridium difficile associated disease (CDAD).

The objective of this study is to establish diagnostic accuracy of ARIES C. difficile Assay through a multi-site, method comparison on prospectively collected, left-over, stool specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).

Study Timeline

• Study First Submitted: 2015-07-09
• Study First Submitted QC: 2015-07-10
• Study First Posted: 2015-07-14
• Study Start: 2016-10
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1021

Inclusion Criteria

• The specimen is from a patient suspected of having C. difficile associated disease (CDAD).
• The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site.

Exclusion Criteria

• The specimen is preserved.
• The specimen was not properly collected, transported, processed or stored according to the instructions provided by the sponsor.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy will be a composite expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).	Within the first year of sample collection

Trial Locations

Locations (4)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Indiana University Health; 🇺🇸 Indianapolis, Indiana, United States

TriCore Reference Laboratories; 🇺🇸 Albuquerque, New Mexico, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States