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Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection

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ClinicalTrials.gov Identifier: NCT02687529
Recruitment Status : Recruiting
First Posted : February 22, 2016
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
QIAGEN Gaithersburg, Inc

Brief Summary:
To compare the positivity rate of the investigational assay to the currently approved QuantiFERON-TB Gold In-Tube assay.

Condition or disease Intervention/treatment
Tuberculosis Device: CST001

Study Type : Observational
Estimated Enrollment : 565 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection
Study Start Date : October 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

Group/Cohort Intervention/treatment
Low Risk
Tested with CST001
Device: CST001
Known Risk
Tested with CST001
Device: CST001



Primary Outcome Measures :
  1. Determination of TB infection. [ Time Frame: 1 day (At time of enrollment) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have either a low risk or known risk for TB exposure.
Criteria

Low Risk and Known Risk Cohorts

Inclusion Criteria:

  • Compensated and uncompensated members (current or future) of the Department of Veterans Affairs with no identified symptoms of active TB disease
  • Age greater than 18 years or less than 80 years.

Exclusion Criteria:

  • Currently taking therapy for active tuberculosis or latent TB infection for more than 14 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687529


Contacts
Contact: Ashley Knights, PhD. (301) 944-7108 ashley.knights@qiagen.com

Locations
United States, California
VA Palo Alto Health Care System (VAPAHCS) Recruiting
Palo Alto, California, United States, 94304
Contact: Mark Holodniy, MD    650-852-3408    mark.holodniy@va.gov   
Contact: Wendy Thanassi, MD    650-493-5000 ext 65214    Wendy.Thanassi@va.gov   
Principal Investigator: Mark Holodniy, MD         
Sub-Investigator: Wendy Thanassi, MD         
Sponsors and Collaborators
QIAGEN Gaithersburg, Inc

Publications:
Responsible Party: QIAGEN Gaithersburg, Inc
ClinicalTrials.gov Identifier: NCT02687529     History of Changes
Other Study ID Numbers: CST001_USA7
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017

Keywords provided by QIAGEN Gaithersburg, Inc:
Tuberculosis
TB

Additional relevant MeSH terms:
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections