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New treatment option for Tuberculosis, Pulmonary
Official title Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TB
ClinicalTrials.gov ID: NCT07672405
What this study is testing
What is sorfequiline?
sorfequiline is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for tuberculosis, pulmonary.
Also referred to as TBAJ876, S.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
- Of non-childbearing potential OR using effective birth control methods
- Body weight ≥ 35 k
You likely can't join 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Port Elizabeth, Bethelsdorp, South Africa
- Pretoria, Guateng, South Africa
- Cape Town, Mowbray, South Africa
- Rustenburg, North West, South Africa
- Brits, North West Provinvce, South Africa
- Durban, Wentworth, South Africa
- East London, South Africa
- Dar es Salaam, Tanzania
- Mbeya, Tanzania
- Moshi, Tanzania
- Mwanza, Tanzania
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Port Elizabeth, Bethelsdorp, South Africa; Pretoria, Guateng, South Africa; Cape Town, Mowbray, South Africa; Rustenburg, North West, South Africa; Brits, North West Provinvce, South Africa; Durban, Wentworth, South Africa and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.