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Xpert MTB/RIF Test in the Diagnosis of Pulmonary Tuberculosis

NCT04433195 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6900

Last updated 2022-05-12

No results posted yet for this study

Summary

Currently in Taiwan, most clinicians use sputum smear and culture for the diagnosis of pulmonary tuberculosis (TB) and apply nucleic acid amplification (NAA) test in a selected manner. In 2013, the World Health Organization issued conditional recommendation that Xpert MTB/RIF may be used rather than conventional microscopy and culture as the initial diagnostic test in all adults suspected of having TB. The newly published Taiwan guidelines for TB diagnosis and treatment has recommended NAA test, together with smear and culture, as the initial diagnostic test in individuals suspected of having TB. The investigators conduct a prospective study to investigate the use of Xpert MTB/RIF as the initial diagnostic test of pulmonary TB under a pragmatic trial design.

Conditions

  • Pulmonary Tuberculosis Confirmation by Culture

Interventions

DIAGNOSTIC_TEST

Xpert MTB/RIF test

Xpert MTB/RIF performed as the initial diagnostic test for the diagnosis of pulmonary TB

Sponsors & Collaborators

  • Buddhist Tzu Chi General Hospital

    collaborator OTHER

  • Chest Hospital, Ministry of Health and Welfare, Taiwan

    collaborator OTHER_GOV

  • Chang-Hua Hospital

    collaborator OTHER_GOV

  • Taichung Veterans General Hospital

    collaborator OTHER

  • Taipei Medical University WanFang Hospital

    lead OTHER

Principal Investigators

  • Chen-Yuan Chiang, MD,DrPhilos · Wan Fang Hospital, Taipei Medical University, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2021-10-31
Completion
2022-12-31
FDA Device
Yes

Countries

  • Taiwan

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 NCT04433195 on ClinicalTrials.gov