Trial Outcomes & Findings for Evaluation of the QuantiFERON-TB Test. (NCT NCT02142894)

Last Updated: 2019-06-18

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

33 participants

Primary outcome timeframe

At time of enrollment

Results posted on

2019-06-18

Participant Flow

A total of 33 subjects were enrolled.

Participant milestones

Participant milestones
Measure	Symptomatic Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay. CST001
Overall Study STARTED	33
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Symptomatic Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay. CST001
Overall Study Protocol Violation	8

Baseline Characteristics

Evaluation of the QuantiFERON-TB Test.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Symptomatic n=33 Participants Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay. CST001
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants

PRIMARY outcome

Timeframe: At time of enrollment

Outcome measures

Outcome measures
Measure	Symptomatic n=33 Participants Evaluation of clinical sensitivity of the CST001 assay in patients who have clinical signs/symptoms indicating TB disease.
Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity	29 Participants

Adverse Events

Symptomatic

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

Clinical Study Coordinator

QIAGEN Sciences

Phone: 301-944-7094

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place