Tuberculosis Clinical Trial
Official title:
A Natural History Study of Multidrug-Resistant Tuberculosis Strains and Host Susceptibility Genes in Korean Patients With Pulmonary Tuberculosis
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:
- Medical history, including past treatments for TB, and review of medical records
- Interview about home and work
- Sputum collection to test for the kind of TB bacteria present and for genetic studies of
the bacteria
- Drug treatment for TB
- Blood draws as part of regular patient care, for HIV testing, and for genetic studies
- Chest x-rays as part of routine patient care
- In patients with recurrent disease, examination of the strains from both bouts of
disease to determine if it is a recurrence of the same organism or infection with a new
strain.
Healthy volunteers undergo the following tests and procedures:
- Brief medical history
- Blood draw to look for exposure to TB and for genetic studies
- Review of previous x-ray to look for active TB
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 avoid these
complications.
Our study population will consist of subjects with pulmonary tuberculosis receiving treatment
at our study sites. Healthy volunteers will be selected as the genotypic control population.
All subjects with tuberculosis enrolled in the study will be followed by periodic chart
review and data extraction during their treatment and follow-up at participating study sites.
For 2.5 years after completing drug treatment, tuberculosis recurrence among study subjects
will be identified using periodic chart abstraction and follow-up phone calls every 6 months
to determine the 2 year recurrence rate for tuberculosis (TB). M. tuberculosis isolates may
be collected from subjects with recurrent TB and analyzed to distinguish between relapse and
re-infection.
Study subjects will be asked to provide 10 mL of blood and 5 to 30 mL of sputum for acid-fast
bacilli (AFB) smear and culture at entry. Sputum will be cultured for M. tuberculosis and
isolates will be tested for drug resistance (DR). The research staff may use molecular DR
tests to confirm the 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 their participation in the
study (treatment and follow-up).
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