At a glance
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A Phase 2, Partially-blinded, Randomised Trial Assessing the Safety and Efficacy of TBAJ-876 or Bedaquiline, in Combination With Pretomanid and Linezolid in Adult Participants With Newly Diagnosed, Drug-sensitive, Smear-positive Pulmonary Tuberculosis
In Brief
A Phase 2 clinical trial evaluating sorfequiline, Pretomanid, and 4 other interventions for Pulmonary TB and 2 related conditions. Active but no longer recruiting, targeting 309 participants across 22 sites in 5 countries.
Detailed Summary
The goal of this clinical trial is to evaluate 3 dose levels of TBAJ876 for 8 weeks in combination with pretomanid and linezolid, compared to 8 weeks of Isoniazid, rifampicin, pyrazinamide and ethambutol (2HRZE), in adult participants with newly diagnosed, smear-positive, pulmonary drug sensitive tuberculosis (DS-TB). The main questions the trial aims to answer are: * What is the optimal dose of TBAJ876 to continue further in development. * What is the bactericidal activity of bedaquiline with pretomanid and linezolid (B-Pa-L) compared to 2HRZE and TBAJ876-Pa-L over 8 weeks * What is the efficacy and safety of the 26-week B-Pa-L regimen compared with the SOC (2HRZE/4HR) in participants with DS-TB. Participants will be seen regularly during treatment (up to 26 weeks) and follow-up (52 weeks post treatment) for safety and efficacy assessments, including but not limited to: * Safety labs, ECGs, vital signs, physical exams, PK sampling, neuropathy assessments and adverse event monitoring * Sputum collection
Study Details
Timeline
Interventions
tablet
tablet
tablet
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fixed doe combination tablets
fixed dose combination tablets