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Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TB

RecruitingPhase 2Ages 18 Years - 65 YearsAllGlobal Alliance for TB Drug Development
NCT07672405 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • sorfequiline
  • Pretomanid
  • Linezolid
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Where

12 sites
Durban International Clinical Research Site
Wentworth, South Africa
Isango Lethemba TB Research Unit
Port Elizabeth, South Africa
Setshaba Research Centre
Soshanguve, South Africa
University of Capetown Lung Institute
Cape Town, South Africa
The Aurum Institute, Rustenburg
Rustenburg, South Africa
Madiberg Centre for Research
Brits, South Africa
Perinatal HIV Research Unit, Tshepong Hospital
Klerksdorp, South Africa
Synergy Biomed Research Institute
East London, South Africa

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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