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Trial Outcomes & Findings for Evaluation of the QuantiFERON-TB Test. (NCT NCT02253537)

NCT ID: NCT02253537

Last Updated: 2019-06-18

Results Overview

Subjects who have clinical signs/symptoms indicating TB and who are receiving or have to start the treatment for active TB were tested. Subjects who were presenting with symptoms suggestive of TB disease and who have a positive acid-fast bacillus (AFB) smear or have Mycobacterium tuberculosis (MTB) in a specimen detected by nucleic acid amplification (NAA) or MTB complex Polymerase Chain Reaction (PCR), and who have received treatment for no more than 14 days upon enrollment.

Recruitment status

COMPLETED

Target enrollment

15 participants

Primary outcome timeframe

At time of enrollment

Results posted on

2019-06-18

Participant Flow

Participant milestones

Participant milestones
Measure
Symptomatic
Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay. CST001
Overall Study
STARTED
15
Overall Study
COMPLETED
15
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the QuantiFERON-TB Test.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Symptomatic
n=15 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
12 Participants
n=5 Participants
Age, Categorical
>=65 years
3 Participants
n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
6 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=5 Participants
Race (NIH/OMB)
White
3 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Region of Enrollment
United States
15 Participants
n=5 Participants

PRIMARY outcome

Timeframe: At time of enrollment

Subjects who have clinical signs/symptoms indicating TB and who are receiving or have to start the treatment for active TB were tested. Subjects who were presenting with symptoms suggestive of TB disease and who have a positive acid-fast bacillus (AFB) smear or have Mycobacterium tuberculosis (MTB) in a specimen detected by nucleic acid amplification (NAA) or MTB complex Polymerase Chain Reaction (PCR), and who have received treatment for no more than 14 days upon enrollment.

Outcome measures

Outcome measures
Measure
Symptomatic
n=15 Participants
Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay. CST001
Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity
13 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

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place