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Evaluation of the QuantiFERON-TB Test.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Brief Summary:
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.

Condition or disease Intervention/treatment
Tuberculosis Device: CST001

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.

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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group/Cohort Intervention/treatment
Symptomatic
Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.
Device: CST001



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with bacteriologically confirmed and untreated TB disease.
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

Information from the National Library of Medicine

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


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90089
Sponsors and Collaborators
QIAGEN Gaithersburg, Inc
Investigators
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Principal Investigator: Brenda Jones, MD University of Southern California
Publications:
QuantiFERON - TB Gold Package Insert (Doc. No. US05990301L). March 2013. Cellestis Inc.

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Responsible Party: QIAGEN Gaithersburg, Inc
ClinicalTrials.gov Identifier: NCT02142894    
Other Study ID Numbers: CST001_USA1
First Posted: May 20, 2014    Key Record Dates
Results First Posted: June 6, 2019
Last Update Posted: June 18, 2019
Last Verified: June 2019
Keywords provided by QIAGEN Gaithersburg, Inc:
Tuberculosis
TB
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections