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

Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497417
• Other study ID #: LMA-CDF-01-CS-001
• Status: Completed
• Phase: N/A
• First received: July 9, 2015
• Last updated: August 22, 2017
• Start date: October 2016
• Est. completion date: February 2017

Study information

• Verified date: August 2017
• Source: Luminex Molecular Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1021
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastroenteritis
• Infectious Colitis

Locations

Country	Name	City	State
United States	TriCore Reference Laboratories	Albuquerque	New Mexico
United States	The Ohio State University	Columbus	Ohio
United States	Indiana University Health	Indianapolis	Indiana
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Luminex Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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