NCT02497417

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,021 (actual)
• Sponsor: Luminex Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Gastroenteritis
• Infectious Colitis

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2015-07-14
• Last updated: 2017-08-23

Locations

4 sites across 1 country: United States