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

NCT01587469 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 992

Last updated 2018-02-06

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Annie Luetkemeyer, MD · San Francisco General Hospital

  • Cynthia Firnhaber, MD · University of Witwatersrand, South Africa

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-02-21
Completion
2014-02-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01587469 on ClinicalTrials.gov