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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02497417
Other study ID # LMA-CDF-01-CS-001
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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