Clinical trial NCT01326013: A Two-Arm, Multi-Centre Clinical Evaluation of the xTAG Gastrointestinal Pathogen Panel
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious
Colitis
Gastroenteritis
Keywords: Stool
Feces
Gastrointestinal
Pathogen
Panel
xTAG GPP
Infectious colitis
Gastroenteritis
Detection
Lead sponsor: Luminex Molecular Diagnostics
Sponsor class: INDUSTRY
First posted: 2011-03-30
Enrollment: 1534
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: St. Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Nashville
country: United States
facility: Vanderbilt University Medical Centre
state: Tennessee
city: Temple
country: United States
facility: Scott and White Memorial Hospital
state: Texas
city: Hamilton
country: Canada
facility: St. Joseph's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Luminex Molecular Diagnostics
name: Jeremy Liu, Ph.D
role: STUDY_DIRECTOR
affiliation: MOUNT SINAI HOSPITAL
name: Tony Mazzulli, M.D., F.R.C.P.(C), FACP
role: PRINCIPAL_INVESTIGATOR
affiliation: Scott and White Hospital & Clinic
name: Robert C. Fader, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph's Hospital
name: James Mahony, Ph.D, FCCM, FAAM
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Centre
name: Yi-Wei Tang, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Louis Children's Hospital
name: Richard Buller, Ph.D., D(ABMM)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Donna M. Wolk, Ph.D., D.(ABMM)
role: PRINCIPAL_INVESTIGATOR
References: