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

Cepheid

Status: Completed

Conditions: Tuberculosis

Study type: Observational

Funder types: NETWORK; Industry; Other U.S. Federal agency

Identifiers

NCT01587469

ACTG A5295

Details and patient eligibility

About

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.

Enrollment: 992 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

992 participants in 1 patient group

HIV-infected and -uninfected individuals

Description:

HIV-infected and -uninfected individuals with suspected TB infection