Development of Molecular Diagnostic Platform for Tuberculosis

Asan Medical Center

Status: Unknown

Conditions: Tuberculosis

Treatments: Diagnostic Test: New technique vs Xpert

Study type: Interventional

Funder types: Other

Identifiers

NCT04734236

RapidassaytestforTB

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Under 18 years

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

New technique group

Active Comparator group

Treatment:

Diagnostic Test: New technique vs Xpert

Xpert group

Sham Comparator group

Treatment:

Diagnostic Test: New technique vs Xpert