Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
To compare the sensitivity of the CST001 assay to the QuantiFERON-TB Gold assay in patients with bacteriologically confirmed and untreated TB disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic | Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CST001 | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity | 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. | At time of enrollment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with bacteriologically confirmed and untreated TB disease.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | QuantiFERON - TB Gold Package Insert (Doc. No. US05990301L). March 2013. Cellestis Inc. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Symptomatic | Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay. CST001 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Symptomatic | Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay. CST001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity | 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. | Posted | Count of Participants | Participants | At time of enrollment |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Symptomatic | Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay. CST001 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Coordinator | QIAGEN Sciences | 301-944-7094 | andrew.schumacher@qiagen.com |
Not provided
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
Not provided
Not provided
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |