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Development of Molecular Diagnostic Platform for Tuberculosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04734236
Recruitment Status : Recruiting
First Posted : February 2, 2021
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Sei Won Lee, Asan Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tuberculosis Diagnostic Test: New technique vs Xpert Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Development of a Rapid and Accurate Diagnostic Assay for Tuberculosis by Using New Sample Preparation and Detection Technique
Actual Study Start Date : January 28, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: New technique group Diagnostic Test: New technique vs Xpert
New technique vs Xpert
Sham Comparator: Xpert group Diagnostic Test: New technique vs Xpert
New technique vs Xpert


Outcome Measures
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Primary Outcome Measures :
  1. The effectiveness of new diagnostic technique [ Time Frame: Time Frame: An average of 2 year ]
    sensitivity and specificity of new test


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Under 18 years
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04734236


Contacts
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Contact: Seiwon Lee 82-10-3010-3990 iseiwon@gmail.com

Locations
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Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine Recruiting
Seoul, Songpa, Korea, Republic of, 05505
Contact: Sei Won Lee, MD PhD    +82-2-3010-3990    iseiwon@gmail.com   
Sponsors and Collaborators
Asan Medical Center
More Information
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Responsible Party: Sei Won Lee, Dr, Asan Medical Center
ClinicalTrials.gov Identifier: NCT04734236    
Other Study ID Numbers: RapidassaytestforTB
First Posted: February 2, 2021    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Infections