Development of Molecular Diagnostic Platform for Tuberculosis

Not Applicable

• Conditions: Tuberculosis
• Interventions: Diagnostic Test: New technique vs Xpert

• Registration Number: NCT04734236
• Lead Sponsor: Asan Medical Center

Brief Summary

This study evaluates new technique for diagnosis of tuberculosis. Among patients who are suspected with tuberculosis, participants will be tested conventional method including Xpert TB/RIF assay, and new diagnostic technique using homobifunctionalImidoesters compounds.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-01-28
• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-01-28
• Last Update Submitted: 2021-01-28
• Study First Posted: 2021-02-02
• Last Update Posted: 2021-02-02
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients who are suspected with pulmonary tuberculosis, tuberculosis meningitis, tuberculosis peritonitis, tuberculosis pleurisy

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Exclusion Criteria

• Under 18 years

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xpert group	New technique vs Xpert	-
New technique group	New technique vs Xpert	-

Primary Outcome Measures

Name	Time	Method
The effectiveness of new diagnostic technique	Time Frame: An average of 2 year	sensitivity and specificity of new test

Trial Locations

Locations (1)

Asan Medical Center, University of Ulsan College of Medicine; 🇰🇷 Seoul, Songpa, Korea, Republic of