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

NCT01326013 | Completed

• 1 other identifier: TDP-736-189
• Study Type: observational
• Target: 1,534
• Locations: 2 countries
• Sites: 6

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.

Conditions

Infectious; Colitis; Gastroenteritis

Keywords

Stool; Feces; Gastrointestinal; Pathogen; Panel; xTAG GPP; Infectious colitis; Gastroenteritis; Detection

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Luminex Molecular Diagnostics: lead

Study Sites (6)

University of Arizona

Tucson, Arizona, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, United States

Location

Vanderbilt University Medical Centre

Nashville, Tennessee, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

St. Joseph's Hospital

Hamilton, Ontario, L8N 4A6, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool

MeSH Terms

Conditions

Communicable Diseases; Colitis; Gastroenteritis

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Jeremy Liu, Ph.D

  Luminex Molecular Diagnostics

  STUDY DIRECTOR

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

  MOUNT SINAI HOSPITAL

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: March 30, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 24, 2012

Record last verified: 2012-08

Locations

CA (2); US (4)