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Consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis will be interviewed for demographic and medical information, and then will be asked to provide 3-4 expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis and rifampin resistance.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xpert MTB/RIF Ultra | Device | Next generation Xpert MTB/RIF assay, this cartridge is intended for the detection of M. tuberculosis in sputum as well as the detection of M. tuberculosis mutations associated with resistance to rifampin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in sensitivity and specificity (ability to correctly identify those with TB and those without TB) between Xpert Ultra and Xpert MTB/ for Mycobacterium tuberculosis (MTB) detection (non-inferiority endpoint) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Xpert Ultra for MTB detection (ability to correctly identify those with TB i.e. true positives), stratified by smear status | Day 1 | |
| Sensitivity and specificity (ability to correctly identify those with TB resistant to Rifampin and those with TB susceptible to Rifampin) of Xpert Ultra for detection of Rifampin (RIF) resistance |
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Case Detection Group
Inclusion Criteria:
Exclusion Criteria:
Drug-Resistant TB Group
Inclusion Criteria:
Exclusion Criteria:
• none
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Individuals who have symptoms consistent with pulmonary TB presenting to participating centres.
Two groups of participants will be recruited, namely a 'Case Detection Group' and a 'Drug-Resistant TB Group'.
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| Name | Affiliation | Role |
|---|---|---|
| Claudia M Denkinger, MD, PhD | Find | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Republican Research and Practical Centre for Pulmonology and Tuberculosis | Minsk | Belarus | ||||
| Clinical Research Unit, National Center for Tuberculosis and Lung Diseases |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| D004194 | Disease |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| Day 1 |
| Difference in sensitivity and specificity (ability to correctly identify those with TB resistant to Rifampin and those with TB susceptible to Rifampin) of Xpert Ultra and Xpert MTB/RIF for detection of RIF resistance | Day 1 |
| Proportion of test attempts that do not yield a determinate result for Xpert Ultra and for Xpert MTB/RIF | Day 1 |
| Tbilisi |
| Georgia |
| National Institute for Research in Tuberculosis | Madras | India |
| Dept of Microbiology, Hinduja Hospital | Mumbai | India |
| New Delhi Tuberculosis Centre | New Delhi | India |
| Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Science, University of the Witwatersrand, and The National Priority Program of the National Health Laboratory Service | Johannesburg | South Africa |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |