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
33
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 P25-P50 for all trials
Started May 2014
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
May 16, 2014
CompletedFirst Posted
Study publicly available on registry
May 20, 2014
CompletedStudy Start
First participant enrolled
May 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2016
CompletedResults Posted
Study results publicly available
June 6, 2019
CompletedJune 18, 2019
June 1, 2019
1.8 years
May 16, 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
To evaluate the clinical sensitivity of the CST001 assay in patients who have clinical signs/symptoms strongly indicating TB disease and who are receiving or have to start treatment for active TB, and whom Mycobacterium tuberculosis (MTB) is confirmed by bacteriological culture. Patients included in the testing either had a positive acid-fast bacillus (AFB) smear of have MTB in a specimen detected by nucleic acid amplification (NAA) of 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 Southern California
Los Angeles, California, 90089, 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
Study Officials
- PRINCIPAL INVESTIGATOR
Brenda Jones, MD
University of Southern California
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
May 16, 2014
First Posted
May 20, 2014
Study Start
May 27, 2014
Primary Completion
March 28, 2016
Study Completion
March 28, 2016
Last Updated
June 18, 2019
Results First Posted
June 6, 2019
Record last verified: 2019-06