Trials / Completed
CompletedNCT01587469
Evaluation of Xpert MTB/RIF Assay for the Rapid Identification of TB and TB Rifampin Resistance in Pulmonary Tuberculosis Suspects
Evaluation of Xpert MTB/RIF Assay for the Rapid Identification of TB and TB Rifampin Resistance in HIV-Infected and HIV-Uninfected Pulmonary Tuberculosis Suspects
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 992 (actual)
- Sponsor
- Cepheid · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This observational Mycobacterium tuberculosis (MTB) diagnostics evaluation study is a longitudinal study of pulmonary TB suspects who are undergoing sputum evaluation for pulmonary TB. The sensitivity and specificity of the Xpert MTB/RIF (Mycobacterium tuberculosis/rifampin) assay performed on the first sputum collected for Xpert testing will be compared to gold standard conventional culture methods on two sputum specimens, in HIV-infected and HIV-uninfected participants.
Conditions
Timeline
- Start date
- 2012-05-01
- Primary completion
- 2014-02-21
- Completion
- 2014-02-21
- First posted
- 2012-04-30
- Last updated
- 2018-02-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01587469. Inclusion in this directory is not an endorsement.