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

Gastroenteritis Clinical Trial

Official title:

A Two-Arm, Multi-Centre Clinical Evaluation of the xTAG Gastrointestinal Pathogen Panel (xTAG GPP) in Patients With Signs and Symptoms of Infectious Colitis and Gastroenteritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326013
• Other study ID #: TDP-736-189
• Status: Completed
• Phase: Phase 2
• First received: March 29, 2011
• Last updated: August 22, 2012
• Start date: June 2011
• Est. completion date: March 2012

Study information

• Verified date: August 2012
• Source: Luminex Molecular Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

The xTAG GPP assay is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify bacterial (and toxins), viral, and parasitic pathogens extracted from human stool specimens collected from patients with signs and symptoms of infectious colitis or gastroenteritis.

The objective of this study is to establish the diagnostic accuracy of xTAG GPP through a multi-site, method comparison study on prospectively collected, left-over, and anonymized stool specimens. The prospective sample set will also be supplemented with pre-selected archived left-over specimens (for low prevalence targets only). Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity for each target.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1534
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis
• Communicable Diseases
• Gastroenteritis
• Infection
• Infectious

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Luminex Molecular Diagnostics

Countries where clinical trial is conducted

United States,  Canada,