Status:
COMPLETED
Multi-Drug Resistant Tuberculosis in Korea
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
International Tuberculosis Research Center
National Masan Tuberculosis Hospital
Conditions:
Tuberculosis
Eligibility:
All Genders
20+ years
Brief Summary
This study, conducted in Korea, will examine why some people are more susceptible to tuberculosis (TB) than others and why some strains of M tuberculosis (the bacteria that causes TB) are more difficu...
Detailed Description
This natural history study seeks to determine some of the mycobacterial and host factors involved in the failure of antituberculous chemotherapy, disease recurrence, and the development of multidrug r...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- For the new cases disease group (Cohort A):
- Age greater than or equal to 20 years old;
- Primary treatment (new TB subject by WHO definition) for tuberculosis without treatment interruption (greater than or equal to 60 days) and with at least 4 months of treatment remaining;
- Clinical signs or symptoms suggestive of tuberculosis;
- Sputum AFB smear-positivity or confirmed MTB using any molecular test
- For previously treated disease group (Cohort B):
- Age greater than or equal to 20 years old;
- Treated for tuberculosis previously with more than 30 days of drug treatment and either:
- a treatment interruption of greater than or equal to 60 days (includes relapse and treatment after interruption), or
- who have experienced treatment failure or have chronic TB.
- Clinical signs or symptoms suggestive of tuberculosis;
- Sputum AFB smear-positivity or confirmed MTB using any molecular test
- For healthy controls (Cohort C):
- Age greater than or equal to 20 years old;
- No previous diagnosis of TB as reported by the subject;
- EXCLUSION CRITERIA:
- For TB Subjects
- 1\. Women who report themselves to be pregnant or possibly pregnant during the protocol introduction and consent process (pregnant women are not normally treated at NMTH).
- For Healthy Volunteers:
- Women who report themselves to be pregnant or those found to be pregnant by a urine Beta-HCG test during the protocol introduction and consent process.
- Those having a chest X-ray suggestive of active tuberculosis.
Exclusion
Key Trial Info
Start Date :
January 3 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 29 2018
Estimated Enrollment :
777 Patients enrolled
Trial Details
Trial ID
NCT00341601
Start Date
January 3 2005
End Date
January 29 2018
Last Update
April 5 2018
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
National Masan Tuberculosis Hospital & Clinical Research Center
Masan, South Korea
2
National Medical Center
Seoul, South Korea