Development of a Rapid and Accurate Diagnostic Assay for Tuberculosis

NCT ID: NCT03423550

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-16

Study Completion Date

2021-12-30

Brief Summary

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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

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Conditions

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Tuberculosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants who are suspected with TB

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Under 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sei Won Lee

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Seiwon Lee

Role: CONTACT

Phone: 82-10-3010-3990

Email: [email protected]

Facility Contacts

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Sei Won Lee, MD

Role: primary

Other Identifiers

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2018-0020

Identifier Type: -

Identifier Source: org_study_id