NCT00341601

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
777

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
11.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2018

Completed
Last Updated

April 5, 2018

Status Verified

January 29, 2018

First QC Date

June 19, 2006

Last Update Submit

April 4, 2018

Conditions

Tuberculosis

Keywords

Mycobacterium TuberculosisTLR-2Recurrent TuberculosisPhenolic GlycolipidmRNA Expression Profiles

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • 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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • For TB Subjects
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Masan Tuberculosis Hospital & Clinical Research Center

Masan, South Korea

Location

National Medical Center

Seoul, South Korea

Location

Related Publications (7)

  • 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. doi: 10.4049/jimmunol.169.6.3155.

    PMID: 12218133BACKGROUND

  • Acocella G, Conti R. Interaction of rifampicin with other drugs. Tubercle. 1980 Sep;61(3):171-7. doi: 10.1016/0041-3879(80)90007-0. No abstract available.

    PMID: 7003868BACKGROUND

  • 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.

    PMID: 9315765BACKGROUND

  • Choi H, Lee M, Chen RY, Kim Y, Yoon S, Joh JS, Park SK, Dodd LE, Lee J, Song T, Cai Y, Goldfeder LC, Via LE, Carroll MW, Barry CE 3rd, Cho SN. Predictors of pulmonary tuberculosis treatment outcomes in South Korea: a prospective cohort study, 2005-2012. BMC Infect Dis. 2014 Jul 2;14:360. doi: 10.1186/1471-2334-14-360.

    PMID: 24990578DERIVED

  • Song T, Park Y, Shamputa IC, Seo S, Lee SY, Jeon HS, Choi H, Lee M, Glynne RJ, Barnes SW, Walker JR, Batalov S, Yusim K, Feng S, Tung CS, Theiler J, Via LE, Boshoff HI, Murakami KS, Korber B, Barry CE 3rd, Cho SN. Fitness costs of rifampicin resistance in Mycobacterium tuberculosis are amplified under conditions of nutrient starvation and compensated by mutation in the beta' subunit of RNA polymerase. Mol Microbiol. 2014 Mar;91(6):1106-19. doi: 10.1111/mmi.12520. Epub 2014 Feb 26.

    PMID: 24417450DERIVED

  • Cho E, Shamputa IC, Kwak HK, Lee J, Lee M, Hwang S, Jeon D, Kim CT, Cho S, Via LE, Barry CE 3rd, Lee JS. Utility of the REBA MTB-Rifa(R) assay for rapid detection of rifampicin resistant Mycobacterium tuberculosis. BMC Infect Dis. 2013 Oct 15;13:478. doi: 10.1186/1471-2334-13-478.

    PMID: 24128118DERIVED

  • Mukundan H, Kumar S, Price DN, Ray SM, Lee YJ, Min S, Eum S, Kubicek-Sutherland J, Resnick JM, Grace WK, Anderson AS, Hwang SH, Cho SN, Via LE, Barry C 3rd, Sakamuri R, Swanson BI. Rapid detection of Mycobacterium tuberculosis biomarkers in a sandwich immunoassay format using a waveguide-based optical biosensor. Tuberculosis (Edinb). 2012 Sep;92(5):407-16. doi: 10.1016/j.tube.2012.05.009. Epub 2012 Jun 17.

    PMID: 22710249DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Clifton E Barry, Ph.D.

    National Institute of Allergy and Infectious Diseases (NIAID)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

January 3, 2005

Study Completion

January 29, 2018

Last Updated

April 5, 2018

Record last verified: 2018-01-29

Locations

KR(2)