Gastroenteritis Clinical Trial
Official title:
A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients
Verified date | August 2017 |
Source | Luminex Molecular Diagnostics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Luminex Corporation |
United States,
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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