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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
Sponsor:
Information provided by (Responsible Party):
QIAGEN Gaithersburg, Inc

Tracking Information
First Submitted Date May 16, 2014
First Posted Date May 20, 2014
Results First Submitted Date September 18, 2018
Results First Posted Date June 6, 2019
Last Update Posted Date June 18, 2019
Actual Study Start Date May 27, 2014
Actual Primary Completion Date March 28, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2019)
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.
Original Primary Outcome Measures
 (submitted: May 16, 2014)
Determination of TB infection [ Time Frame: At time of enrollment ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of the QuantiFERON-TB Test.
Official Title Evaluation of the 4th Generation QuantiFERON-TB Test (CST001) for the Detection of Tuberculosis Infection
Brief Summary To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
Detailed Description The objective of the study was to enroll patients who have clinical signs/symptoms strongly indicating TB and who are receiving of have to start the treatment for active TB, and test the variants of the CST001 assay to support the evaluation of clinical sensitivity.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with bacteriologically confirmed and untreated TB disease.
Condition Tuberculosis
Intervention Device: CST001
Study Groups/Cohorts Symptomatic
Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.
Intervention: Device: CST001
Publications * QuantiFERON - TB Gold Package Insert (Doc. No. US05990301L). March 2013. Cellestis Inc.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 27, 2019)
33
Original Estimated Enrollment
 (submitted: May 16, 2014)
60
Actual Study Completion Date March 28, 2016
Actual Primary Completion Date March 28, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02142894
Other Study ID Numbers CST001_USA1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party QIAGEN Gaithersburg, Inc
Study Sponsor QIAGEN Gaithersburg, Inc
Collaborators Not Provided
Investigators
Principal Investigator: Brenda Jones, MD University of Southern California
PRS Account QIAGEN Gaithersburg, Inc
Verification Date June 2019