Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 29, 2011
August 22, 2012
June 2011
February 2012   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01326013 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Two-Arm, Multi-Centre Clinical Evaluation of the xTAG Gastrointestinal Pathogen Panel
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

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Stool

Probability Sample

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.

  • Infectious
  • Colitis
  • Gastroenteritis
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1534
March 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01326013
TDP-736-189
No
Luminex Molecular Diagnostics
Luminex Molecular Diagnostics
Not Provided
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
Luminex Molecular Diagnostics
August 2012

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