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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00341601 |
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 difficult to treat or become resistant to drug treatments. The study will compare blood samples and other medical information from patients with different kinds of tuberculosis and with healthy volunteers to identify patient and bacterial characteristics that contribute to disease susceptibility, treatment failure, disease recurrence and multi-drug resistance.
Healthy volunteers and patients with tuberculosis who are 20 years of age or older may be eligible for this study. Subjects are recruited from among patients receiving treatment for tuberculosis at the National Masan Tuberculosis Hospital in the Republic of Korea and from healthy people visiting government health care centers for annual medical checkups. The latter include people who have had TB but are cured; people who have been exposed to TB, but currently have no signs of disease; and those who have not been exposed to TB.
Participants with tuberculosis undergo the following tests and procedures:
Healthy volunteers undergo the following tests and procedures:
Condition |
Tuberculosis Pulmonary Tuberculosis |
MedlinePlus related topics: | Tuberculosis |
Study Type: | Observational |
Official Title: | A Natural History Study of Multidrug-Resistant Tuberculosis Strains and Host Susceptibility Genes in Korean Patients With Pulmonary Tuberculosis |
Estimated Enrollment: | 2040 |
Study Start Date: | December 2004 |
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 resistance by M. tuberculosis. Despite optimal treatment with directly-observed short-course therapy (DOTS), about 5-10% of compliant patients with (cured) tuberculosis relapse, usually within a year after completion of therapy. In Korea, where DOTS is not practiced, the relapse rate has been reported to be 15 to 20 %. In individual patients, failure to eradicate disease contributes directly to the development of drug-resistance and to low overall cure rates. While factors such as patient drug compliance and HIV status have been extensively studied in relation to rates of relapse; host genetic factors and the specific relevance of the infecting mycobacterial strain have not yet been investigated in detail. Identification of patient characteristics and specific strains of M. tuberculosis that are associated with relapse and the evolution of drug resistance would greatly facilitate the development of treatment protocols that might avert these complications.
Our study population will consist of patients with pulmonary tuberculosis receiving treatment at the National Masan Tuberculosis Hospital (NMTH), the largest tertiary referral center for patients with previously treated and drug-resistant tuberculosis in the Republic of Korea. The hospital also serves as a site where the local population (approximately 1,000,000) is treated as inpatients for new cases of tuberculosis. Healthy volunteers will be selected as the genotypic control population. All patients withnew cases of tuberculosis enrolled in the study will be followed by periodic chart review and data extraction during their treatment by NMTH. For 2.5 years after completing drug treatment, patient recurrence will be queried using the recently implemented tuberculosis registration system to determine the 2 year recurrence rate for TB, and the patient's M. tuberculosis isolates will be cultured upon readmission and analyzed to distinguish between relapse and re-infection.
Study patients will be asked to volunteer to have 20 mL of blood collected by hospital staff during normal admission testing, as well as a 5 to 30 mL sample of sputum for acid-fast bacilli (AFB) smear and culture. Patients will have their sputum cultured for M. tuberculosis by the hospital diagnostic laboratory and isolates will be tested for drug resistance (DR). The research staff will use molecular DR tests to confirm the hospital's agar-growth DR results. In addition, subjects will be asked a series of medical history questions including history of prior tuberculosis, antituberculous treatment, disease contacts, and risk factors associated with tuberculosis; and will be asked to give consent to allow clinical research staff to abstract treatment regimens and results from their inpatient and outpatient medical charts for the duration of treatment.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
For the new cases disease group:
Age greater than or equal to 20 years old;
Primary treatment (new TB patient 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.
For previously treated disease group:
Age greater than or equal to 20 years old;
Treated for tuberculosis previously with more than 30 days of drug treatment:
Clinical signs or symptoms suggestive of tuberculosis;
Sputum AFB smear-positivity.
For healthy controls:
Age greater than or equal to 20 years old;
No previous diagnosis of TB as reported by the subject;
EXCLUSION CRITERIA:
For TB Patients
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 (as interpreted by the Health District's radiologist for healthy controls and by NMTH's consulting radiologist for the individuals screened at the hospital).
Contact: Laura E. Via, Ph.D. | (301) 451-9554 | lvia@niaid.nih.gov |
Korea, Republic of | |||||
National Masan Tuberculosis Hospital & Clinical Research Center | Recruiting | ||||
Masan, Korea, Republic of | |||||
Yonsei University College of Medicine | Recruiting | ||||
Seoul, Korea, Republic of | |||||
Sub-Investigator: Sang Cho, D.V.M., Ph.D. | |||||
Sub-Investigator: Seok-Yong Eum, D.V.M., Ph.D. | |||||
Sub-Investigator: Hye-Young Lee, Ph.D. | |||||
Masan Government Health Care Center | Recruiting | ||||
Masan, Korea, Republic of | |||||
International Tuberculosis Research Center (ITRC) | Recruiting | ||||
Masan, Korea, Republic of |
Study ID Numbers: | 999905069, 05-I-N069 |
First Received: | June 19, 2006 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00341601 |
Health Authority: | United States: Federal Government |
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