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Development of Automated Molecular Diagnostic Platform for Tuberculosis Diagnosis (New Assay TB)

NCT04988984 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2021-08-04

No results posted yet for this study

Summary

It is intended for patients who have been admitted to the outpatient or emergency room or are hospitalized For patients who diagnose pulmonary tuberculosis or extrapulmonary tuberculosis using Xpert TB/RIF, additionally, diagnose pulmonary tuberculosis or extrapulmonary tuberculosis using a new diagnostic method, and check the test results. Check whether the tuberculosis bacteria were actually cultured in the sample in the future, and compare the sensitivity and specificity in each test.

Validation in animal model In an animal model (rat) with chronic obstructive pulmonary disease that shows similar characteristics to tuberculosis destructive lung, It will be investigated whether the HI method can be validated by separating and concentrating microbiome for various pathogens including Mycobacterium tuberculosis using HI method. Confirm.

Conditions

  • Tuberculosis Infection

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Seiwon Lee · Asan Medical Center

Eligibility

Min Age
19 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2020-11-17
Completion
2023-12-31

Countries

  • South Korea

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 NCT04988984 on ClinicalTrials.gov