Development of Molecular Diagnostic Platform for Tuberculosis

NCT ID: NCT04734236

Last Updated: 2021-02-02

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

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-28

Study Completion Date

2021-12-31

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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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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New technique group

Group Type ACTIVE_COMPARATOR

New technique vs Xpert

Intervention Type DIAGNOSTIC_TEST

New technique vs Xpert

Xpert group

Group Type SHAM_COMPARATOR

New technique vs Xpert

Intervention Type DIAGNOSTIC_TEST

New technique vs Xpert

Interventions

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New technique vs Xpert

New technique vs Xpert

Intervention Type DIAGNOSTIC_TEST

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

Maximum Eligible Age

80 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

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asan Medical Center, University of Ulsan College of Medicine

Seoul, Songpa, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Seiwon Lee

Role: CONTACT

82-10-3010-3990

Facility Contacts

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Sei Won Lee, MD PhD

Role: primary

+82-2-3010-3990

Other Identifiers

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RapidassaytestforTB

Identifier Type: -

Identifier Source: org_study_id

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