Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01269268

Enrollment

270

Registered

2011-01-04

Start date

2010-06-30

Completion date

2014-05-14

Last updated

2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Tuberculosis

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Characterization of antigens of Mycobacterium tuberculosis K strain for serodiagnosis of tuberculosis	6months

Countries

South Korea

Outcome results