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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

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Tuberculosis
Intervention Device: CST001
Enrollment 33
Recruitment Details  
Pre-assignment Details A total of 33 subjects were enrolled.
Arm/Group Title Symptomatic
Hide Arm/Group Description

Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.

CST001

Period Title: Overall Study
Started 33
Completed 25
Not Completed 8
Reason Not Completed
Protocol Violation             8
Arm/Group Title Symptomatic
Hide Arm/Group Description

Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.

CST001

Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
<=18 years
0
   0.0%
Between 18 and 65 years
32
  97.0%
>=65 years
1
   3.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
9
  27.3%
Male
24
  72.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Hispanic or Latino
19
  57.6%
Not Hispanic or Latino
14
  42.4%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
American Indian or Alaska Native
0
   0.0%
Asian
7
  21.2%
Native Hawaiian or Other Pacific Islander
1
   3.0%
Black or African American
3
   9.1%
White
21
  63.6%
More than one race
1
   3.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants
33
1.Primary Outcome
Title Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity
Hide Description 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.
Time Frame At time of enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symptomatic
Hide Arm/Group Description:
Evaluation of clinical sensitivity of the CST001 assay in patients who have clinical signs/symptoms indicating TB disease.
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
29
  87.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symptomatic
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The results are analyzed in a 2x2 contingency table with 95%CI.
Method of Estimation Estimation Parameter 2 x 2 contingency table
Estimated Value 87.9
Confidence Interval (2-Sided) 95%
72.7 to 95.2
Estimation Comments [Not Specified]
Time Frame From 27th May 2014 to 28th Mar 2016.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Symptomatic
Hide Arm/Group Description Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.
All-Cause Mortality
Symptomatic
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Symptomatic
Affected / at Risk (%)
Total   0/33 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Symptomatic
Affected / at Risk (%)
Total   0/33 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Study Coordinator
Organization: QIAGEN Sciences
Phone: 301-944-7094
EMail: andrew.schumacher@qiagen.com
Publications:
QuantiFERON - TB Gold Package Insert (Doc. No. US05990301L). March 2013. Cellestis Inc.
Layout table for additonal information
Responsible Party: QIAGEN Gaithersburg, Inc
ClinicalTrials.gov Identifier: NCT02142894    
Other Study ID Numbers: CST001_USA1
First Submitted: May 16, 2014
First Posted: May 20, 2014
Results First Submitted: September 18, 2018
Results First Posted: June 6, 2019
Last Update Posted: June 18, 2019