Tuberculosis
Conditions
Interventions
Sponsors
TB Alliance
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to undertaking any trial-related procedures. 2. Participants aged 18 to 65 years, inclusive. 3. Body weight (in light clothing and no shoes) =35 kg. 4. Sputum positive for tubercle bacilli (at least 1+ on the IUATLD/WHO scale [Section 13.4] on smear microscopy) at the trial laboratory. 5. DS-TB participants defined as the following: a. Sensitive to rifampicin and isoniazid by rapid sputum-based test AND b. Either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB. 6. A chest x-ray during the screening period or within 14 days of screening which in the opinion of the investigator is compatible with pulmonary TB. 7. Be of non-childbearing potential OR using effective methods of birth control
Exclusion criteria
Exclusion criteria: 1. History or presence of pulmonary, hepatic, musculoskeletal abnormalities, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, psychiatric disease 2. Cardiovascular abnormalities 3. Karnofsky performance status score of 450 msec at screening visit. 12. Participants with any of the following at the screening visit per medical history: a. A personal or family history of congenital QT prolongation, b. A history of known, untreated, and uncontrolled hypothyroidism, c. A history of or ongoing bradyarrhythmia, d. A history of Torsade de Pointe. 13. Unstable Diabetes Mellitus which required hospitalization for hyper- or hypo-glycemia within the past year prior to the start of screening. 14. Females who have a positive pregnancy test during the screening visit or are already known to be pregnant, breastfeeding, or planning to conceive a child during the trial or within 6 months of completing treatment with IMP. Males planning to conceive a child during the trial or within 6 months of stopping treatment with IMP. 15. Any diseases or conditions in which the use of standard TB drugs or any of their components is contra-indicated, including but not limited to drug allergy. 16. Use of any drug within 30 days prior to randomisation known to prolong QTc interval.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to stable sputum culture conversion to negative status using data from weekly cultures through 8 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with a favourable outcome at 26 weeks after the end of treatment. | — |
Countries
Tanzania, Uganda
Contacts
Public ContactHarriet;Nyanda Elias Mayanja Kizza;Ntinginya
National PI Uganda;National PI Tanzania
Outcome results
None listed