NCT04734236

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 28, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

January 28, 2021

Last Update Submit

January 28, 2021

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • The effectiveness of new diagnostic technique

    sensitivity and specificity of new test

    Time Frame: An average of 2 year

Study Arms (2)

New technique group

ACTIVE COMPARATOR
Diagnostic Test: New technique vs Xpert

Xpert group

SHAM COMPARATOR
Diagnostic Test: New technique vs Xpert

Interventions

New technique vs XpertDIAGNOSTIC_TEST

New technique vs Xpert

New technique groupXpert group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, Songpa, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Central Study Contacts

Seiwon Lee

CONTACT

82-10-3010-3990iseiwon@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 2, 2021

Study Start

January 28, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)