Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341601
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2006-06-19
Brief Title:
Multi-Drug Resistant Tuberculosis in Korea
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Natural History Study of Multidrug-Resistant Tuberculosis Strains and Host Susceptibility Genes in Korean Patients With Pulmonary Tuberculosis
Status:
COMPLETED
Status Verified Date:
2018-01-29
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 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 25 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
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 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-I-N069 | None | None | None |