Tuberculosis
Conditions
Brief 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.
Interventions
None listed
Sponsors
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Centers for Disease Control and Prevention
Cepheid
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of all participants with Xpert MTB/RIF Assay MTB positive in sputum #1 who are AFB smear positive and MGIT culture positive for M.tuberculosis. | Week 0 |
| Proportion of all participants with Xpert MTB/RIF Assay MTB positive in sputum #1 who are AFB smear negative and MGIT culture positive for M.tuberculosis. | Week 0 |
| Proportion of US participants with Xpert MTB/RIF Assay MTB negative in sputum #1 who are MGIT culture negative for M.tuberculosis. | Week 0 |
Countries
United States
Outcome results
None listed