Measurement of Anti-TB Drugs in Lung Tissue From Patients Having Surgery to Treat Tuberculosis
Status:
Completed
Trial end date:
2017-12-29
Target enrollment:
Participant gender:
Summary
This study, conducted jointly by researchers at the National Masan TB Hospital, Asan and
Samsung Medical Centers in Seoul, Republic of Korea, and the Yonsei University and the NIH in
the United States, will examine why some patients with tuberculosis (TB) develop disease that
is harder to treat than most cases. TB is an infection of the lung that usually can be
successfully treated with anti-TB drugs. However, some people get a more serious kind of
disease (called multi-drug resistant TB or extensively drug-resistant TB) that is very
difficult to treat and may not be cured by the regular medicines available. This study will
try to find out if some of the common TB drugs are getting to the place where the TB bacteria
are. It will also look at how current anti-TB drugs might be used more effectively and how
better drugs might be developed.
People 20 years of age and older with hard-to-treat TB who have elected to undergo surgical
removal of part of their lung at the National Masan Tuberculosis Hospital, Masan, the Asan
Medical Center, and the Samsung Medical Center, may be eligible for this study.
Participants undergo the following procedures:
- Medical history and physical examination, including sputum sample.
- Blood tests at various times during the study.
- Drug administration. Subjects are given one dose each of five common TB drugs
rifampicin, isoniazid, pyrazinamide, kanamycin and moxifloxacin before they undergo
surgery to remove part of their lung. After surgery, some of the lung tissue and fluid
around the lungs that was removed during surgery will be examined to determine the
regions where the TB bacteria live and analyze the lung tissue itself.
- Dynamic MRI (magnetic resonance imaging) scan. This type of scan uses a magnetic field
and radio waves to produce pictures of the lung. Subjects lie very still on a table
inside the cylindrical scanner with their head on a soft cradle and their hands over
their head. Several images are obtained for less than 5 minutes at a time.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
Asian Medical Center International Tuberculosis Research Center Korean Center for Disease Control and Prevention Novartis Institute for Tropical Medicine