Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis

Active Tuberculosis Clinical Trial

Official title:

Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269268
• Other study ID #: 4-2010-0213
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Active Tuberculosis
• Tuberculosis

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