Background:
Tuberculosis (TB) is a bacterial lung infection. Typical treatment using anti-TB drugs lasts
about 6 months. Some people with less severe TB might not need to take the drugs that long.
Researchers think a PET/CT lung scan along with estimating how much TB is in the lungs might
show who will be cured after only 4 months of treatment.
Objective:
To demonstrate that 4 months of treatment is not inferior to 6 months of treatment for people
with less severe TB.
Eligibility:
People 18-75 years old who have TB treatable with standard TB drugs
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
HIV test
Sputum sample: Participants will be asked to cough sputum into a cup.
Chest x-ray
Participants will start TB drugs. They will have visits at weeks 1, 2, 4, 8, 12, and about 6
more times during the 18-month study. Visits include:
Sputum samples
Physical exam
Blood tests
PET/CT scans at 2-3 visits: Participants fast for about 6 hours before the scan. Participants
get FDG, a type of sugar that gives off a small amount of radiation, through an arm vein.
They lie on a table in a machine that takes pictures of the body.
Chest x-rays at 1-2 visits
Participants who we believe are likely to be cured at 4 months will be randomly assigned to
get either 6 months of treatment or 4 months of treatment.
Participants may be asked to join a substudy using their sputum samples or additional blood
tests.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)