Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TB
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Tuberculosis, Pulmonary
In brief
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.
Key facts
- Study ID
- NCT07672405
- Run by
- Global Alliance for TB Drug Development
- People needed
- 100
- Starts
- 2026-07-09
- Expected to finish
- 2028-06-24
- Last updated by the study team
- 2026-07-15
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- DS-TB as defined as sensitive to rifampicin and isoniazid by rapid sputum-based test AND 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
- Of non-childbearing potential OR using effective birth control methods
- Body weight ≥ 35 k
You may not qualify if…
- Karnofsky score < 60 at screening
- Any evidence of extrapulmonary TB
- Cardiovascular or QT prolongation risk factors Pregnant or breast-feeding
- Laboratory abnormalities as defined in the protocol. • For participants living with HIV only:
- CD4+ count<200 cells/μL.
- WHO Clinical Stage 4 HIV disease
- Participant does not agree to use DTG/TFV/3TC during study treatment if ARV therapy is indicated
- If initiation of ARV therapy is indicated, participants who are known to be intolerant, non-responsive to DTG/TFV/3TC or have DTG/TFV/3TC as a contraindication.
Where it is running
- Isango Lethemba TB Research Unit — Port Elizabeth, Bethelsdorp, South Africa (enrolling)
- Setshaba Research Centre — Pretoria, Guateng, South Africa (enrolling)
- Durban International Clinical Research Site, Enhancing Care Foundation — Durban, Wentworth, South Africa (enrolling)
- The Aurum Institute, Rustenburg — Rustenburg, North West, South Africa
- Madiberg Centre for Research — Brits, North West Provinvce, South Africa
- National Instittute for Medical Research — Mwanza, Tanzania
- Synergy Biomed Research Institute — East London, South Africa
- INUKA Africa — Dar es Salaam, Tanzania
- Mbeya Referral Hospital — Mbeya, Tanzania
- Kilimanjaro Clinical Research Instuute — Moshi, Tanzania
- University of Capetown Lung Institute — Cape Town, Mowbray, South Africa
Full record on ClinicalTrials.gov
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