Condition: Tuberculosis, Pulmonary · Sponsor: Global Alliance for TB Drug Development
The goal of this interventional trial is to evaluate the safety and efficacy of the loading dose regimen 200/100SPaL-4/13 weeks, and the 100SPaL -17 weeks regimen in adults with newly diagnosed, drug-sensitive, smear-positive pulmonary tuberculosis. Participants (18-65 years) will be randomised 1:1, stratified by country and disease severity, to receive either : 1. a sorfequiline loading-dose regimen (200 mg daily for 4 weeks followed by 100 mg daily for 13 weeks) plus pretomanid 200 mg and linezolid 600 mg daily, or 2. sorfequiline 100 mg daily for 17 weeks plus pretomanid 200 mg and linezolid 600 mg daily. Study treatment is administered orally once daily with food. The primary objective is to assess safety through 17 weeks of treatment, including treatment-emergent adverse events, ECG findings, vital signs, laboratory assessments, visual acuity, and peripheral neuropathy. Secondary objectives include assessments of efficacy (time to stable sputum culture conversion; favorable outcome and treatment failure/relapse at 26 and 52 weeks after end of treatment) and pharmacokinetics of trial drugs, with exploratory analyses including predictors of culture conversion, exposure-response relationships, and quality of life.
This description comes directly from the study's public registry record.
Leandra Lombard · +27 83 30 76784 · leandra.lombard@tballiance.org
Morounfolu Olugbosi, MD · +27 79 045 4917 · morounfolu.olugbosi@tballiance.org
Always discuss trial participation with your own doctor first.
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| Setshaba Research Centre | Pretoria, Guateng, South Africa | Recruiting |
| University of Capetown Lung Institute | Cape Town, Mowbray, South Africa | Not Yet Recruiting |
| The Aurum Institute, Rustenburg | Rustenburg, North West, South Africa | Not Yet Recruiting |
| Madiberg Centre for Research | Brits, North West Provinvce, South Africa | Not Yet Recruiting |
| Durban International Clinical Research Site, Enhancing Care Foundation | Durban, Wentworth, South Africa | Recruiting |
| Synergy Biomed Research Institute | East London, South Africa | Not Yet Recruiting |
| INUKA Africa | Dar es Salaam, Tanzania | Not Yet Recruiting |
| Mbeya Referral Hospital | Mbeya, Tanzania | Not Yet Recruiting |
| Kilimanjaro Clinical Research Instuute | Moshi, Tanzania | Not Yet Recruiting |
| National Instittute for Medical Research | Mwanza, Tanzania | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07672405