Tests sorfequiline-based treatment for new drug-sensitive lung tuberculosis
Tests sorfequiline combination treatment in adults newly diagnosed with lung tuberculosis.
Plain-language title generated from the registry record
Registry title: Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TB
Key facts
- Where
- Brits, Cape Town, East London, Klerksdorp, Port Elizabeth, Rustenburg, Soshanguve, and Wentworth, South AfricaSee the 8 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07672405, who can take part
Where in South Africa
- Madiberg Centre for ResearchBrits, South AfricaTaking people
- University of Capetown Lung InstituteCape Town, South AfricaTaking people
- Synergy Biomed Research InstituteEast London, South AfricaNot yet recruiting
- Perinatal HIV Research Unit, Tshepong HospitalKlerksdorp, South AfricaNot yet recruiting
- Isango Lethemba TB Research UnitPort Elizabeth, South AfricaTaking people
- The Aurum Institute - RustenburgRustenburg, South AfricaTaking people
- Setshaba Research CentreSoshanguve, South AfricaTaking people
- WentworthWentworth, South AfricaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Global Alliance for TB Drug Development
- Trial code
- NCT07672405
- Record updated
- 19 August 2026
- Original description
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.Read full original descriptionShow less
A Phase 2b, Randomised, Multi-center, Partially Blinded Trial Assessing the Safety and Efficacy of Regimens Containing Sorfequiline, Pretomanid and Linezolid in Adults With Newly Diagnosed, Drug-sensitive, Smear Positive Pulmonary Tuberculosis
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.
Inclusion: 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.
Exclusion: 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; Karnofsky score < 60 at screening; Any evidence of extrapulmonary TB.