- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02253537
Evaluation of the QuantiFERON-TB Test.
June 5, 2019 updated by: QIAGEN Gaithersburg, Inc
Evaluation of the 4th Generation QuantiFERON-TB Test (CST001) for the Detection of Tuberculosis Infection
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
Study Overview
Detailed Description
To compare the sensitivity of the CST001 assay to the QuantiFERON-TB Gold assay in patients with bacteriologically confirmed and untreated TB disease.
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Washington
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Seattle, Washington, United States, 98195
- University of Washington
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with bacteriologically confirmed and untreated TB disease.
Description
Inclusion Criteria:
- Clinical symptoms consistent with a high probability of having TB disease
- Receiving, or are likely to receive, therapy for active TB
- Confirmed tuberculosis by either AFB smear and culture testing, or Nucleic Acid Amplification methods and culture testing.
- Between 18 and 70 years of age.
Exclusion Criteria:
- Taken therapy for active TB or latent TB for more than 14 days
- Culture confirmation of M. tuberculosis not obtained
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Symptomatic
Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity
Time Frame: At time of enrollment
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Subjects who have clinical signs/symptoms indicating TB and who are receiving or have to start the treatment for active TB were tested.
Subjects who were presenting with symptoms suggestive of TB disease and who have a positive acid-fast bacillus (AFB) smear or have Mycobacterium tuberculosis (MTB) in a specimen detected by nucleic acid amplification (NAA) or MTB complex Polymerase Chain Reaction (PCR), and who have received treatment for no more than 14 days upon enrollment.
|
At time of enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- QuantiFERON - TB Gold Package Insert (Doc. No. US05990301L). March 2013. Cellestis Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2015
Primary Completion (Actual)
April 26, 2016
Study Completion (Actual)
April 26, 2016
Study Registration Dates
First Submitted
September 29, 2014
First Submitted That Met QC Criteria
September 30, 2014
First Posted (Estimate)
October 1, 2014
Study Record Updates
Last Update Posted (Actual)
June 18, 2019
Last Update Submitted That Met QC Criteria
June 5, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CST001_USA5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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