At a glance
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NexGen EBA Radiologic and Immunologic Biomarkers of Sterilizing Drug Activity in Tuberculosis
In Brief
A Phase 2 clinical trial evaluating Treatment, PET/CT Scan, and 1 other intervention for Pulmonary Tuberculosis. Completed, enrolled 262 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Different Drug combinations
PET/CT Scans
Sample Collection