NexGen EBA Radiologic and Immunologic Biomarkers of Sterilizing Drug Activity in Tuberculosis
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|ClinicalTrials.gov Identifier: NCT02371681|
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : May 7, 2021
- 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.
- To learn the effect of different anti-TB drugs on microbiological, radiographic and immunologic markers in people with TB.
- Adults age 18-65 who weigh 30-90 kg and have common TB bacteria that can be treated with common TB medicines.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Tuberculosis||Drug: Treatment Radiation: PET/CT Scan Procedure: Sample Collection||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||262 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||NexGen EBA Radiologic and Immunologic Biomarkers to Enhance Early Bactericidal Activity Measurements of Sterilizing Drug Activity in Tuberculosis|
|Study Start Date :||February 25, 2015|
|Actual Primary Completion Date :||September 1, 2017|
|Actual Study Completion Date :||November 14, 2017|
Different Drug combinations
Radiation: PET/CT Scan
Procedure: Sample Collection
- To characterize, in the context of a standard EBA study, the effect of various antituberculosis drugs on radiographic and immunologic markers as measured by PET /CT and immunologic assays [ Time Frame: 14 days ]To characterize, in the context of a standard EBA study, the effect of various antituberculosis drugs on radiographic and immunologic markers as measured by PET /CT and immunologic assays, in subjects with drug sensitive pulmonary tuberculosis who have not received anti-TB treatment within the last 3 years.A description of the individual markers that change over time is of interest to better understand both the markers and the effects of each treatment.
- PET/CT Changes [ Time Frame: 14 days ]Correlation of PET/CT changes with treatment response, microbiologic and immunologic outcomes
- Rank order of drugs [ Time Frame: 14 days ]Comparison of the rank order of drugs based upon bacteriologic, radiologic and immunologic features.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371681
|Stellenbosch University, Faculty of Medicine and Health Sciences|
|Cape Town, South Africa|
|TASK Applied Sciences|
|Cape Town, South Africa|
|Principal Investigator:||Clifton E Barry, Ph.D.||National Institute of Allergy and Infectious Diseases (NIAID)|