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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luminex Molecular Diagnostics
ClinicalTrials.gov Identifier:
NCT01326013
First received: March 29, 2011
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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.


Condition Phase
Infectious
Colitis
Gastroenteritis
Phase 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Luminex Molecular Diagnostics:

Biospecimen Retention:   Samples With DNA

Stool


Enrollment: 1534
Study Start Date: June 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Blinded, Prospective Arm
Diagnostic accuracy for higher prevalence targets will be evaluated in prospectively collected, anonymized, leftover, stool specimens.
Blinded, Pre-selected Arm
For targets that exhibit lower prevalence rates in the intended use population, banked, pre-selected, positive clinical specimens will be tested.

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Clinical specimens collected from patients with signs and symptoms of infectious colitis or gastroenteritis who are either hospitalized, admitted to emergency departments or visiting outpatient clinics.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326013

Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States
United States, Tennessee
Vanderbilt University Medical Centre
Nashville, Tennessee, United States
United States, Texas
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
Canada, Ontario
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Luminex Molecular Diagnostics
Investigators
Study Director: Jeremy Liu, Ph.D Luminex Molecular Diagnostics
Principal Investigator: Tony Mazzulli, M.D., F.R.C.P.(C), FACP Mount Sinai Hospital, New York
Principal Investigator: Robert C. Fader, Ph.D Scott and White Hospital & Clinic
Principal Investigator: James Mahony, Ph.D, FCCM, FAAM St. Joseph's Hospital
Principal Investigator: Yi-Wei Tang, M.D., Ph.D Vanderbilt University Medical Centre
Principal Investigator: Richard Buller, Ph.D., D(ABMM) St. Louis Children's Hospital
Principal Investigator: Donna M. Wolk, Ph.D., D.(ABMM) University of Arizona
  More Information

No publications provided

Responsible Party: Luminex Molecular Diagnostics
ClinicalTrials.gov Identifier: NCT01326013     History of Changes
Other Study ID Numbers: TDP-736-189
Study First Received: March 29, 2011
Last Updated: August 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Luminex Molecular Diagnostics:
Stool
Feces
Gastrointestinal
Pathogen
Panel
xTAG GPP
Infectious colitis
Gastroenteritis
Detection

Additional relevant MeSH terms:
Colitis
Communicable Diseases
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 28, 2014