InfectiousNCT01326013
A Two-Arm, Multi-Centre Clinical Evaluation of the xTAG Gastrointestinal Pathogen Panel
An observational study of Infectious and Colitis, run by Luminex Molecular Diagnostics at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infectious, Colitis, Gastroenteritis
- How many people
- 1,534 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jun 2011to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- The specimen is a preserved stool, stool in Cary-Blair media or rectal swab.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
Vanderbilt University Medical Centre
Nashville, Tennessee
St. Louis Children's Hospital
St Louis, Missouri
Scott and White Memorial Hospital
Temple, Texas, 76508
University of Arizona
Tucson, Arizona
Canada2 sites
St. Joseph's Hospital
Hamilton, Ontario, L8N 4A6
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
About this study
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
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.
Read the 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.
- Conditions
- Infectious, Colitis, Gastroenteritis
- Keywords
- Stool, Feces, Gastrointestinal, Pathogen, Panel, xTAG GPP, Infectious colitis, Gastroenteritis, Detection
- Medical subject headings
- Communicable Diseases, Colitis, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectiousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luminex Molecular Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeremy Liu, Ph.D, Study director, Luminex Molecular DiagnosticsTony Mazzulli, M.D., F.R.C.P.(C), FACP, Principal investigator, MOUNT SINAI HOSPITALRobert C. Fader, Ph.D, Principal investigator, Scott and White Hospital & ClinicJames Mahony, Ph.D, FCCM, FAAM, Principal investigator, St. Joseph's HospitalYi-Wei Tang, M.D., Ph.D, Principal investigator, Vanderbilt University Medical CentreRichard Buller, Ph.D., D(ABMM), Principal investigator, St. Louis Children's HospitalDonna M. Wolk, Ph.D., D.(ABMM), Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326013
- Sponsor's protocol ID
- TDP-736-189
- Status last verified
- Aug 2012
- First submitted
- 29 Mar 2011
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01326013
- Acronym / sponsor ID
- TDP-736-189
- Conditions
- Infectious, Colitis, Gastroenteritis
- Keywords
- Stool, Feces, Gastrointestinal, Pathogen, Panel, xTAG GPP, Infectious colitis, Gastroenteritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,534 participants (actual)
- Lead sponsor
- Luminex Molecular DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 30 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- The specimen is a preserved stool, stool in Cary-Blair media or rectal swab.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Liu, Ph.D study director
Luminex Molecular Diagnostics
Tony Mazzulli, M.D., F.R.C.P.(C), FACP principal investigator
MOUNT SINAI HOSPITAL
Robert C. Fader, Ph.D principal investigator
Scott and White Hospital & Clinic
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious and Colitis, run by Luminex Molecular Diagnostics at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2012.