A Phase 2, partially-blinded, randomised trial assessing the safety and efficacy of TBAJ876 or bedaquiline, in combination with pretomanid and linezolid in adult participants with newly diagnosed, drug-sensitive, smear-positive pulmonary tuberculosis
- Conditions
- Tuberculosis
- Registration Number
- PACTR202311505748497
- Lead Sponsor
- TB Alliance
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 300
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
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 <60%.
4. Abuse of alcohol or illegal drugs
5. Historical and/or current use of local traditional medications/herbs (such as St. John’s wort)
6. Being, or about to be, treated for malaria.
7. Is critically ill and, in the judgment of the investigator, has a diagnosis likely to result in death during the trial or the follow-up period.
8. Any evidence of extrapulmonary TB. Pleural effusion occupying <50% of hemithorax or concomitant intra- or extra-thoracic lymphadenopathy are not exclusions.
9. For participants living with HIV (as specified by protocol).
10. Having participated in other clinical trials with investigational agents within 8 weeks prior to Day 1 or currently randomised in an investigational drug trial.
11. Participants with QTcF interval on ECG >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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method