Evaluation of the QuantiFERON-TB Test.
Evaluation of the 4th Generation QuantiFERON-TB Test (CST001) for the Detection of Tuberculosis Infection
1 other identifier
observational
15
1 country
1
Brief Summary
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2014
CompletedFirst Posted
Study publicly available on registry
October 1, 2014
CompletedStudy Start
First participant enrolled
February 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2016
CompletedResults Posted
Study results publicly available
June 6, 2019
CompletedJune 18, 2019
June 1, 2019
1.2 years
September 29, 2014
September 18, 2018
June 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity
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
Study Arms (1)
Symptomatic
Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.
Interventions
Eligibility Criteria
Patients with bacteriologically confirmed and untreated TB disease.
You may qualify if:
- 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.
You may not qualify if:
- Taken therapy for active TB or latent TB for more than 14 days
- Culture confirmation of M. tuberculosis not obtained
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington
Seattle, Washington, 98195, United States
Related Publications (1)
QuantiFERON - TB Gold Package Insert (Doc. No. US05990301L). March 2013. Cellestis Inc.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Study Coordinator
- Organization
- QIAGEN Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2014
First Posted
October 1, 2014
Study Start
February 2, 2015
Primary Completion
April 26, 2016
Study Completion
April 26, 2016
Last Updated
June 18, 2019
Results First Posted
June 6, 2019
Record last verified: 2019-06