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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01269268
Other study ID # 4-2010-0213
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2010
Est. completion date May 14, 2014

Study information

Verified date March 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

There was no sensitive and specific biomarker for tuberculosis infection, disease progression and predicting the prognosis of treatment. Therefore, the investigators aimed to investigate and evaluate the newer biomarker for the diagnosis of TB infection. To investigate the new biomarker for TB infection, the investigators will recruit the participants including active TB patients, healthy household contacts, healthy community control.


Recruitment information / eligibility

Status Completed
Enrollment 270
Est. completion date May 14, 2014
Est. primary completion date May 14, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

- active TB patients : diagnosed with active TB through the microbiologic examination, imaging findings

- healthy control : no history of TB treatment, no respiratory symptoms, no evidence of active infectious disease including TB on chest X-ray, no history of close contacts of active pulmonary TB patients

Exclusion Criteria:

- pregnant woman

- positive result of human immunodeficiency virus examination

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Severance Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Characterization of antigens of Mycobacterium tuberculosis K strain for serodiagnosis of tuberculosis 6months
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