Brits

Researchers are evaluating the safety and bactericidal activity of TBD09 combined with other drugs in adults with drug-sensitive pulmonary tuberculosis. This Phase 2 randomized trial aims to determine if these combinations are safe and effective for treating this form of tuberculosis. The study is sponsored by the Gates Medical Research Institute and involves multiple treatment groups with varying doses of TBD09. Participants are assigned to one of five groups receiving different combinations of TBD09, bedaquiline, pretomanid, and linezolid. The TBD09 doses vary from 100 mg three times weekly to 500 mg daily, combined with bedaquiline and pretomanid, or linezolid with bedaquiline and pretomanid. Treatment lasts for 28 days in each group. During the study, participants will be monitored through Day 35 for safety, including serious adverse events, treatment-emergent adverse events, and adverse events leading to treatment discontinuation. Researchers will also assess bactericidal activity up to Day 28 and study pharmacokinetics of TBD09. Additional safety evaluations include blood tests, visual and color vision assessments, and peripheral neuropathy screening. The total participation period covers screening, treatment, and follow-up assessments.

Researchers are evaluating the safety and effectiveness of two sorfequiline-based treatment regimens combined with pretomanid and linezolid for adults aged 18 to 65 years with newly diagnosed, drug-sensitive pulmonary tuberculosis. This phase 2, randomized, multi-center clinical trial aims to compare a loading dose regimen against a steady dose regimen. The study focuses on adults who have smear-positive pulmonary tuberculosis and have not been recently treated for the disease. The primary goal is to assess safety through treatment-emergent adverse events and other health measures, while also exploring effectiveness and drug behavior in the body. Participants will be randomly assigned to one of two treatment groups. One group receives sorfequiline 200 mg daily for 4 weeks followed by 100 mg daily for 13 weeks, along with pretomanid 200 mg and linezolid 600 mg daily. The other group receives sorfequiline 100 mg daily for 17 weeks, with pretomanid and linezolid dosed the same way. All treatments are taken orally once daily with food. The study includes a screening period, a 17-week treatment period, and a follow-up period lasting 52 weeks after treatment ends. During the study, participants will undergo various assessments including safety monitoring through adverse event reporting, ECGs, vital signs, laboratory tests, vision checks, and neuropathy evaluations. Effectiveness will be measured by the time to stable sputum culture conversion and favorable treatment outcomes at 26 and 52 weeks post-treatment. Researchers will also study drug levels and quality of life. The total participation time spans from screening through one year after completing treatment, with regular visits throughout the treatment and follow-up phases.