Evaluation of the QuantiFERON-TB Test.
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|ClinicalTrials.gov Identifier: NCT02142894|
Recruitment Status : Completed
First Posted : May 20, 2014
Results First Posted : June 6, 2019
Last Update Posted : June 18, 2019
|Condition or disease||Intervention/treatment|
|Study Type :||Observational|
|Actual Enrollment :||33 participants|
|Official Title:||Evaluation of the 4th Generation QuantiFERON-TB Test (CST001) for the Detection of Tuberculosis Infection|
|Actual Study Start Date :||May 27, 2014|
|Actual Primary Completion Date :||March 28, 2016|
|Actual Study Completion Date :||March 28, 2016|
Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.
- 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 ]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.
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): NCT02142894
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90089|
|Principal Investigator:||Brenda Jones, MD||University of Southern California|