A randomized controlled trial of two adjunctive host-directed therapies in rifampin-resistant tuberculosis (DRTB-HDT).

You likely can't join if

• 1. Any condition for which participation in the trial, as judged by the investigator, could compromise the subject's well-being or prevent, limit, or confound protocol-specified assessments 2. Current or imminent treatment (within 24 hours) for malaria. 3. Pregnancy or breastfeeding 4. Severely ill, such that, in the opinion of the investigator, death is likely during the trial. 5. TB meningitis or other forms of severe TB with increased risk of poor outcome as judged by the investigator. 6. History of allergy or hypersensitivity to any of the study therapies or related substances. 7. Have participated in other clinical trials with investigational agents within 8 weeks prior to study initiation or currently enrolled in an investigational trial. 8. Previous RIF‐R‐TB treatment within the past 12 months 9. Cardiac arrhythmia requiring medication or any clinically significant ECG abnormality, in the opinion of the investigator 10. Requires treatment with drugs that are strong inducers or inhibitors of CYP3A4 (e.g., ketoconazole, lopinavir, or cobicistat), carbonic anhydrase inhibitors (e.g., acetazolamide), or OCT2 or MATE inhibitors (e.g., cimetidine, pyrimethamine). 11. Use of systemic corticosteroids within the past 28 days. 12. History of unstable diabetes mellitus requiring hospitalization for hyper‐ or hypoglycemia within the past year prior to screening or requiring treatment with metformin. 13. Subjects with any of the following abnormal laboratory values: A. creatinine >2 mg/dl b. hemoglobin <8 g/dL/ . c. platelets <100x109 cells/L d. serum potassium <3.5 e. alanine aminotransferase (ALT) ≥2.0 x ULN f. alkaline phosphatase (AP) >5.0 x ULN g. total bilirubin >1.5 mg/dL h. Hepatitis B surface antigen positive i. random blood glucose >140 mg/dL (7.8 mmol/L) j. SARS-CoV-2 PCR or antigen test positive NB: All inclusion criteria and none of the exclusion criteria must be met. NB: Enrolled patients whose initial sputum cultures subsequently fail to demonstrate RIF-R-TB growth will be excluded from the mITT and PP populations. They may be excluded from further study participation based on the individual benefit-risk ratio, as assessed by the study site, PI and DMC.