Trials / Completed
CompletedNCT03072576
Accuracy and Feasibility of Xpert Ultra
A Multicentre Study of the Diagnostic Accuracy and Feasibility of the Xpert Ultra for Detection of TB and Rifampin Resistance in Adults Suspected of Having Pulmonary TB
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,400 (actual)
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Xpert MTB/RIF Ultra | 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 |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2017-03-01
- Completion
- 2017-10-01
- First posted
- 2017-03-07
- Last updated
- 2018-02-08
Locations
6 sites across 4 countries: Belarus, Georgia, India, South Africa
Source: ClinicalTrials.gov record NCT03072576. Inclusion in this directory is not an endorsement.