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

Completed

• Conditions: Tuberculosis

• Registration Number: NCT01587469
• Lead Sponsor: Cepheid

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-24
• Study First Submitted QC: 2012-04-26
• Study First Posted: 2012-04-30
• Study Start: 2012-05
• Primary Completion: 2014-02-21
• Study Completion: 2014-02-21
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-02
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 992

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ucsf Aids Ctu; 🇺🇸 San Francisco, California, United States