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Accuracy and Feasibility of Xpert Ultra

NCT03072576 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1400

Last updated 2018-02-08

No results posted yet for this study

Summary

Consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis will be interviewed for demographic and medical information, and then will be asked to provide 3-4 expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis and rifampin resistance.

Conditions

  • Tuberculosis, Pulmonary

Interventions

DEVICE

Xpert MTB/RIF Ultra

Next generation Xpert MTB/RIF assay, this cartridge is intended for the detection of M. tuberculosis in sputum as well as the detection of M. tuberculosis mutations associated with resistance to rifampin

Sponsors & Collaborators

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Principal Investigators

  • Claudia M Denkinger, MD, PhD · Find

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-03-31
Completion
2017-10-31

Countries

  • Belarus
  • Georgia
  • India
  • South Africa

Study Locations

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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 NCT03072576 on ClinicalTrials.gov