Evaluation of Xpert MTB/RIF Assay for the Rapid Identification of TB and TB Rifampin Resistance in Pulmonary Tuberculosis Suspects
Completed
Conditions studied: Tuberculosis
In brief
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.
Key facts
- Study ID
- NCT01587469
- Run by
- Cepheid
- People needed
- 992
- Starts
- 2012-05-01
- Expected to finish
- 2014-02-21
- Last updated by the study team
- 2018-02-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Suspected pulmonary TB (more information on the criterion can be found in the protocol)
- Men and women age equal to or greater than 18 years
- Ability and willingness of candidate or legal guardian/representative to provide informed consent
- Collection of two sputum samples for AFB smear and culture collected within 7 days prior to entry.
- Availability of two samples for Xpert MTB/RIF testing collected within 7 days prior to entry.
- Determination and/or documentation of HIV status
- For HIV-positive candidates, a CD4+ cell count obtained within 45 days prior to study entry or drawn at the time of entry at any laboratory that has a CLIA certification or its equivalent.
You may not qualify if…
- Either receipt of ≥48 cumulative hours OR three or more doses of anti-TB treatment within 180 days prior to completion of second sputum collection for Xpert testing
- Receipt of more than 7 cumulative days of antibiotics intended for bacterial treatment that may have anti-tuberculosis activity, within the 14 days prior to first sputum collection
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
Where it is running
- Ucsf Aids Ctu — San Francisco, California, United States
Full record on ClinicalTrials.gov
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