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Application of GeneXpert on Bronchoscopic Samples for Patients Suspicious of TB

NCT02838641 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 219

Last updated 2019-04-17

No results posted yet for this study

Summary

This is an observational study using Bronchial-alveolar lavage (BAL) as specimen for GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis (TB). Patients suspicious of TB, who require bronchoscopy as part of the investigation procedures, will be recruited for this study over a period of 18 months. Clinical likelihood of TB will be systematically scored according to various clinical parameters. This will determine the pre-test probability. Clinician will decide if anti-TB treatment is to be started and patients will be followed up for a minimal of 18 months. Sensitivity, specificity, positive, negative predictive values and the respective likelihood ratio will be calculated accordingly.

Conditions

  • Observation

Interventions

DEVICE

GeneXpert

Real time integrated and automated nucleic acid amplification test for detection of TB

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • Hong Kong

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 NCT02838641 on ClinicalTrials.gov