Trial Outcomes & Findings for Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection (NCT NCT02687529)
NCT ID: NCT02687529
Last Updated: 2019-06-19
Results Overview
To demonstrate the reproducibility of the CST001 assay between 3 external laboratories with 2 operators per site.
Recruitment status
COMPLETED
Target enrollment
66 participants
Primary outcome timeframe
1 day (At time of enrollment)
Results posted on
2019-06-19
Participant Flow
Participant milestones
| Measure |
Low Risk
Tested with CST001
CST001
|
Known Risk
Tested with CST001
CST001
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
32
|
|
Overall Study
COMPLETED
|
34
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection
Baseline characteristics by cohort
| Measure |
Low Risk
n=34 Participants
Tested with CST001
CST001
|
Known Risk
n=32 Participants
Tested with CST001
CST001
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Continuous
|
52.5 years
n=99 Participants
|
58.5 years
n=107 Participants
|
55.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 day (At time of enrollment)To demonstrate the reproducibility of the CST001 assay between 3 external laboratories with 2 operators per site.
Outcome measures
| Measure |
Low Risk
n=34 Participants
Tested with CST001
CST001
|
Known Risk
n=32 Participants
Tested with CST001
CST001
|
|---|---|---|
|
Number of Participants With Concordant CST001 Assay Results for All Replicates Across Three Testing Sites
|
32 Participants
|
23 Participants
|
Adverse Events
Low Risk
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Known Risk
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place