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

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.

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Key information

Conditions

Gastroenteritis Digestive System Diseases Gastrointestinal Diseases Infectious Colitis

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampa General Hospital, Tampa, Florida, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Diagnostic accuracy will be a composite expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).

Time frame: Within the first year of sample collection

Sponsors and collaborators

Lead sponsor

Luminex Corporation

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jul 14, 2015
Registry last updated: Aug 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed