Evaluation of Xpert MTB/RIF Assay for the Rapid Identification of TB and TB Rifampin Resistance in Pulmonary Tuberculosis Suspects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

992 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-02-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Tuberculosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV-infected and -uninfected individuals

HIV-infected and -uninfected individuals with suspected TB infection

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No