A Two-Arm, Multi-Centre Clinical Evaluation of the xTAG Gastrointestinal Pathogen Panel

Completed

Conditions studied: Infectious, Colitis, Gastroenteritis

In brief

The xTAG Gastrointestinal Pathogen Panel (xTAG GPP) is a PCR-based assay to detect the presence or absence of gastrointestinal (GI) pathogens from human stool specimens. The objective of this study is to establish diagnostic accuracy of the xTAG GPP.

Key facts

Study ID

NCT01326013

Run by

Luminex Molecular Diagnostics

People needed

1534

Starts

2011-06-01

Expected to finish

2012-03-01

Last updated by the study team

2012-08-24

Who can join

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

You may qualify if…

• The specimen is stool.
• The specimen is from a pediatric or adult, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility.
• The specimen is from a patient exhibiting clinical signs and symptoms of infectious colitis or gastroenteritis.

You may not qualify if…

• The specimen is a preserved stool, stool in Cary-Blair media or rectal swab.

Where it is running

• University of Arizona — Tucson, Arizona, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Vanderbilt University Medical Centre — Nashville, Tennessee, United States
• Scott and White Memorial Hospital — Temple, Texas, United States
• St. Joseph's Hospital — Hamilton, Ontario, Canada
• Mount Sinai Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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