Tuberculosis Clinical Trial
Official title:
A Natural History Study of Multidrug-Resistant Tuberculosis Strains and Host Susceptibility Genes in Korean Patients With Pulmonary Tuberculosis
Verified date | January 29, 2018 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 777 |
Est. completion date | January 29, 2018 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility |
- INCLUSION CRITERIA: For the new cases disease group (Cohort A): 1. Age greater than or equal to 20 years old; 2. 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; 3. Clinical signs or symptoms suggestive of tuberculosis; 4. Sputum AFB smear-positivity or confirmed MTB using any molecular test For previously treated disease group (Cohort B): 1. Age greater than or equal to 20 years old; 2. Treated for tuberculosis previously with more than 30 days of drug treatment and either: 1. a treatment interruption of greater than or equal to 60 days (includes relapse and treatment after interruption), or 2. who have experienced treatment failure or have chronic TB. 3. Clinical signs or symptoms suggestive of tuberculosis; 4. Sputum AFB smear-positivity or confirmed MTB using any molecular test For healthy controls (Cohort C): 1. Age greater than or equal to 20 years old; 2. 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: 1. 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. 2. Those having a chest X-ray suggestive of active tuberculosis. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | National Masan Tuberculosis Hospital & Clinical Research Center | Masan | |
Korea, Republic of | National Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | International Tuberculosis Research Center, Korean Center for Disease Control and Prevention, National Masan Tuberculosis Hospital |
Korea, Republic of,
Abel B, Thieblemont N, Quesniaux VJ, Brown N, Mpagi J, Miyake K, Bihl F, Ryffel B. Toll-like receptor 4 expression is required to control chronic Mycobacterium tuberculosis infection in mice. J Immunol. 2002 Sep 15;169(6):3155-62. — View Citation
Acocella G, Conti R. Interaction of rifampicin with other drugs. Tubercle. 1980 Sep;61(3):171-7. Review. — View Citation
Agerton T, Valway S, Gore B, Pozsik C, Plikaytis B, Woodley C, Onorato I. Transmission of a highly drug-resistant strain (strain W1) of Mycobacterium tuberculosis. Community outbreak and nosocomial transmission via a contaminated bronchoscope. JAMA. 1997 Oct 1;278(13):1073-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the characteristics of subjects with relapsed tuberculosis verses the characteristics of subjects that do not experience relapse disease | Over course of the study | ||
Secondary | To compare the frequencies of the Toll-like receptor 2 and 4 (TLR2 and TLR4) alleles in tuberculosis subjects and tuberculosis-exposed, healthy volunteers. Other putative susceptibility genes discussed in the background may also be examined. | End of study | ||
Secondary | To compare molecular characteristics, including the expression of the phenolic glycolipid, (PGL) of M. tuberculosis strains that occur in subjects with a prior history of disease, disease spread to nonpulmonary sites, or previously treated disea... | End of study |
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