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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 29, 2011

Last Updated Date

August 22, 2012

Start Date ^ICMJE

June 2011

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01326013 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Stool

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.

Condition ^ICMJE

Infectious
Colitis
Gastroenteritis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1534

Completion Date

March 2012

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT01326013

Other Study ID Numbers ^ICMJE

TDP-736-189

Has Data Monitoring Committee

Responsible Party

Luminex Molecular Diagnostics

Study Sponsor ^ICMJE

Luminex Molecular Diagnostics

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Luminex Molecular Diagnostics

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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