Back to resultsDevelopment of Molecular Diagnostic Platform for Tuberculosis
Primary Purpose
Tuberculosis
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
New technique vs Xpert
Sponsored by
About this trial
This is an interventional diagnostic trial for Tuberculosis
Eligibility Criteria
Inclusion Criteria:
- Patients who are suspected with pulmonary tuberculosis, tuberculosis meningitis, tuberculosis peritonitis, tuberculosis pleurisy
Exclusion Criteria:
- Under 18 years
Sites / Locations
- Asan Medical Center, University of Ulsan College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
New technique group
Xpert group
Arm Description
Outcomes
Primary Outcome Measures
The effectiveness of new diagnostic technique
sensitivity and specificity of new test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04734236
Brief Title
Development of Molecular Diagnostic Platform for Tuberculosis
Official Title
Development of a Rapid and Accurate Diagnostic Assay for Tuberculosis by Using New Sample Preparation and Detection Technique
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 28, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
New technique group
Arm Type
Active Comparator
Arm Title
Xpert group
Arm Type
Sham Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
New technique vs Xpert
Intervention Description
New technique vs Xpert
Primary Outcome Measure Information:
Title
The effectiveness of new diagnostic technique
Description
sensitivity and specificity of new test
Time Frame
Time Frame: An average of 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are suspected with pulmonary tuberculosis, tuberculosis meningitis, tuberculosis peritonitis, tuberculosis pleurisy
Exclusion Criteria:
Under 18 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seiwon Lee
Phone
82-10-3010-3990
Email
iseiwon@gmail.com
Facility Information:
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
State/Province
Songpa
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sei Won Lee, MD PhD
Phone
+82-2-3010-3990
Email
iseiwon@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development of Molecular Diagnostic Platform for Tuberculosis
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