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

NCT ID: NCT01326013

Last Updated: 2012-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1534 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Infectious Colitis Gastroenteritis

Keywords

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Stool Feces Gastrointestinal Pathogen Panel xTAG GPP Infectious colitis Gastroenteritis Detection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Blinded, Prospective Arm

Diagnostic accuracy for higher prevalence targets will be evaluated in prospectively collected, anonymized, leftover, stool specimens.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luminex Molecular Diagnostics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeremy Liu, Ph.D

Role: STUDY_DIRECTOR

Luminex Molecular Diagnostics

Tony Mazzulli, M.D., F.R.C.P.(C), FACP

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Robert C. Fader, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Scott and White Hospital & Clinic

James Mahony, Ph.D, FCCM, FAAM

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Hospital

Yi-Wei Tang, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Centre

Richard Buller, Ph.D., D(ABMM)

Role: PRINCIPAL_INVESTIGATOR

St. Louis Children's Hospital

Donna M. Wolk, Ph.D., D.(ABMM)

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status

St. Louis Children's Hospital

St Louis, Missouri, United States

Site Status

Vanderbilt University Medical Centre

Nashville, Tennessee, United States

Site Status

Scott and White Memorial Hospital

Temple, Texas, United States

Site Status

St. Joseph's Hospital

Hamilton, Ontario, Canada

Site Status

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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TDP-736-189

Identifier Type: -

Identifier Source: org_study_id