Evaluation of the QuantiFERON-TB Test.
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Symptomatic Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay. |
Device: CST001
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity [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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Southern California | Los Angeles | California | United States | 90089 |
Sponsors and Collaborators
- QIAGEN Gaithersburg, Inc
Investigators
- Principal Investigator: Brenda Jones, MD, University of Southern California
Study Documents (Full-Text)
None provided.More Information
Publications
- CST001_USA1
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A total of 33 subjects were enrolled. |
| Arm/Group Title | Symptomatic |
|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Symptomatic |
|---|---|
| Arm/Group Description | Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay. CST001 |
| Overall Participants | 33 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
32
97%
|
| >=65 years |
1
3%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
9
27.3%
|
| Male |
24
72.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
19
57.6%
|
| Not Hispanic or Latino |
14
42.4%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
7
21.2%
|
| Native Hawaiian or Other Pacific Islander |
1
3%
|
| Black or African American |
3
9.1%
|
| White |
21
63.6%
|
| More than one race |
1
3%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
33
100%
|
Outcome Measures
| Title | Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Symptomatic |
|---|---|
| Arm/Group Description | Evaluation of clinical sensitivity of the CST001 assay in patients who have clinical signs/symptoms indicating TB disease. |
| Measure Participants | 33 |
| Count of Participants [Participants] |
29
87.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Symptomatic |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Equivalence | |
| Comments | The results are analyzed in a 2x2 contingency table with 95%CI. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | 2 x 2 contingency table |
| Estimated Value | 87.9 | |
| Confidence Interval |
(2-Sided) 95% 72.7 to 95.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | From 27th May 2014 to 28th Mar 2016. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Symptomatic | |
| Arm/Group Description | Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay. | |
All Cause Mortality |
||
| Symptomatic | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Symptomatic | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/33 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Symptomatic | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/33 (0%) | |
Limitations/Caveats
More Information
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
| Name/Title | Clinical Study Coordinator |
|---|---|
| Organization | QIAGEN Sciences |
| Phone | 301-944-7094 |
| andrew.schumacher@qiagen.com |
- CST001_USA1