Sorfequiline-based regimens for adults with newly diagnosed drug-sensitive pulmonary TB

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, randomized, multi-center trial compares two sorfequiline-containing treatment regimens in adults aged 18–65 with smear-positive, drug-sensitive pulmonary tuberculosis. Participants are randomized 1:1 to receive either a loading-dose regimen (200 mg daily for 4 weeks, then 100 mg daily for 13 weeks) or a 17-week continuous regimen (100 mg daily), each with pretomanid and linezolid, taken orally with food. The primary objective is to assess safety over 17 weeks, including adverse events, ECGs, vital signs, and lab abnormalities; secondary objectives include time to sputum culture conversion and overall favorable outcomes. The study is conducted at multiple sites in South Africa and Tanzania with approximately 100 participants, followed for 52 weeks after treatment. Key eligibility requires rifampicin- and isoniazid-sensitive TB, age 18–65, and adequate body weight, with specific exclusions for health status and HIV-related treatment conditions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Durban International Clinical Research Site
  Wentworth, Durban, South Africa Recruiting
• Isango Lethemba TB Research Unit
  Port Elizabeth, Eastern Cape, South Africa Recruiting
• Setshaba Research Centre
  Soshanguve, Gauteng, South Africa Recruiting
• University of Capetown Lung Institute
  Cape Town, Mowbray, South Africa Recruiting
• The Aurum Institute, Rustenburg
  Rustenburg, North West, South Africa Recruiting
• Madiberg Centre for Research
  Brits, North West Provinvce, South Africa Recruiting

Study contacts

• Study coordinator: Leandra Lombard
• Email: leandra.lombard@tballiance.org
• Phone: +27 83 30 76784

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.