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

Completed

Conditions studied: Gastroenteritis, Infectious Colitis

In brief

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.

Key facts

Study ID

NCT02497417

Run by

Luminex Corporation

People needed

1021

Starts

2016-10-01

Expected to finish

2017-02-01

Last updated by the study team

2017-08-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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