NexGen EBA Radiologic and Immunologic Biomarkers of Sterilizing Drug Activity in Tuberculosis
Status:
Completed
Trial end date:
2017-11-14
Target enrollment:
Participant gender:
Summary
Background:
- Tuberculosis (TB) is a lung infection caused by bacteria. When people with TB cough, they
may spread these bacteria. Researchers are looking for new TB medicines. They want to find a
faster way to tell if a drug might combat TB.
Objective:
- To learn the effect of different anti-TB drugs on microbiological, radiographic and
immunologic markers in people with TB.
Eligibility:
- Adults age 18-65 who weigh 30-90 kg and have common TB bacteria that can be treated with
common TB medicines.
Design:
- Participants will be admitted to the hospital for screening. They will have medical
history, physical exam, and chest radiograph. They will give blood, urine, and sputum
samples.
- Participants will be put in 1 of 8 groups.
- Participants will get one or a combination of TB medicines daily for about 14 days.
- Each day, participants:
- Will discuss side effects.
- May have a physical exam.
- Will spit mucus into a cup. They may breathe in saline water through a nebulizer to make
them cough.
- Participants will have blood taken 3-4 times during the study
- Participants will have 2-3 Fluorodeoxyglucose Positron Emission Tomography/Computed
Tomography (FDG-PET/CT) scans. FDG is a radioactive sugar molecule which helps measure
TB disease in the lungs. It will be injected into a vein. Participants will lie in a
scanner that takes pictures.
- Around study day 14, participants will leave the hospital. They will be referred to a
local TB clinic. There they will get the standard 4 TB medicines. Those in group 8 will
already be on these medicines and will have another FDG-PET/CT on day 28.
- Participants will be in the study for up to 28 days.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)