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Could a 4-Month TB cocktail replace the standard 6-Month cure?
NCT ID NCT05221502
First seen Jun 25, 2026 · Last updated Aug 13, 2026 · Updated 5 times
Summary
This trial tested a new 4-month combination of three drugs (OPC-167832, delamanid, and bedaquiline) against the standard 6-month treatment for drug-susceptible pulmonary tuberculosis. 122 adults with newly diagnosed TB took part. The goal was to see if the shorter regimen is safe and can clear the infection faster.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OPC-167832 combined with delamanid and bedaquiline
- What this could lead to
- If successful, this could lead to a shorter, 4-month treatment for drug-susceptible tuberculosis, reducing the burden of long therapy.
- What could go wrong
- This is an early phase 2 trial with only 122 participants, so results may not confirm safety or effectiveness. The new combination may cause side effects or fail to cure TB as well as the standard 6-month regimen.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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122 people
The number who actually took part.
- Started
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Apr 2022
- Finished
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May 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Able to provide written, informed consent prior to initiation of any trial-related procedures or treatments, and able, in the opinion of the investigator, to comply with all the requirements of the trial. 2. Male or female participants between 18 and 65 years of age (inclusive) at the screening visit. 3. Body weight ≥ 35.0 kg at the screening visit. 4. Newly diagnosed, rifampin and isoniazid susceptible (on the screening sample) pulmonary TB. 5. Able to spontaneously produce sputum. 6. Females of childbearing potential (FOCBP) must agree to use 2 different approved methods of birth control or remain abstinent throughout their participation in the trial and for 12 weeks after the last dose of IMP or dose of RHEZ. 7. Male participants must agree to use 2 different approved methods of birth control or remain abstinent throughout their participation in the trial and for 12 weeks after the last dose of IMP or RHEZ. Exclusion Criteria: 1. Participants are known or suspected of having resistance to rifampin, isoniazid, ethambutol, pyrazinamide, DLM, or BDQ either confirmed by the laboratory, or based on epidemiological history, at screening. 2. Evidence of clinically significant metabolic (for example, including ongoing or current hypokalemia \[ie, potassium \<3.5 mEq/dL at screening\]), gastrointestinal, neurological, psychiatric, endocrine or liver (eg, hepatitis B and C) disease; malignancy; or other abnormalities (other than the indication being studied). 3. History of, or current, clinically relevant cardiovascular disorder such as heart failure, coronary heart disease, uncontrolled hypertension, arrhythmia or symptom strongly suggestive of such a problem (for example, syncope or palpitations), tachyarrhythmia or status after myocardial infarction. 4. Known bleeding disorders or family history of bleeding disorders. 5. Any diseases or conditions in which the use of DLM, BDQ, OPC 167832, rifampin, isoniazid, pyrazinamide, or ethambutol is contraindicated. 6. Any prior treatment for M tuberculosis within the past 2 years. 7. Any treatment with a drug active against M tuberculosis (eg, quinolones) within the 3 months prior to screening. 8. Clinical evidence of severe extrapulmonary TB (eg, miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis). 9. Evidence of pulmonary silicosis, lung fibrosis, or other lung condition considered as severe by the investigator (other than TB). In particular, any underlying condition that could interfere with the assessment of x-ray images, sputum collection, or interpretation of sputum findings, or otherwise compromise the subject's participation in the trial. 10. Any renal impairment characterized by creatinine clearance/estimated glomerular filtration rate (eGFR) of \< 60 mL/min/1.73 m2, or hepatic impairment characterized by alanine transaminase or aspartate transaminase \> 2.0 × upper limit of normal of the clinical laboratory reference range or bilirubin \> 2.0 × upper limit of normal of the clinical laboratory reference range, at screening. 11. Screening glucose (nonfasting) ≥ 200 mg/dL or glycosylated hemoglobin (HbA1c) ≥ 6.5%. 12. QTcF \> 450 msec in male participants (\> 470 msec in female participants), atrioventricular block II or III, bi-fasicular block, at screening or current or history of clinically significant ventricular arrhythmias. Other ECG abnormalities, if considered clinically significant by the investigator. 13. Participants receiving any of the prohibited medications (see Section 6.5.1) within the specified periods or who would be likely to require prohibited concomitant therapy during the trial. 14. Female participants who are breast-feeding or who have a positive pregnancy test result prior to receiving the first dose of IMP or RHEZ on Day 1. 15. Current history of significant drug and/or alcohol abuse that is likely to result in poor adherence to trial requirements or that would pose a risk to the participant's well-being during the course of the trial. 16. History of current hepatitis or carriers of hepatitis B surface antigen (HBsAg) and/or anti hepatitis C virus (HCV). 17. Participants who test positive for cocaine or other drugs of abuse (excluding known prescription stimulants and other prescribed medications and marijuana) at screening are excluded. Detectable levels of alcohol, marijuana, barbiturates, or opiates in the drug screen are not exclusionary if, in the investigator's documented opinion, the participant does not meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for moderate to severe substance use disorder and the positive test does not signal a clinical condition that would impact the safety of the participant or interpretation of the trial results, and participation is agreed to by the medical monitor prior to treatment. 18. History of having taken an investigational drug within 30 days preceding trial entry. 19. A history of difficulty in donating blood. 20. Donation of blood or plasma within 30 days prior to dosing. 21. History of serious mental disorders that, in the opinion of the investigator, would exclude the participant from participating in this trial. 22. Any known prior exposure to OPC-167832, DLM, or BDQ. 23. Participants with significant medical comorbidities that in the opinion of the investigator, should not participate in the trial. 24. Participants with Karnofsky score \< 60 will be excluded from the trial. 25. Participants testing positive for active severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection at screening. 26. Participants with HIV co infection not on a stable anti-retroviral regimen consisting of tenofovir, emtricitabine/ lamivudine, dolutegravir (ie \> 3 months), or who have a detectable viral load, or who have a CD4 count \< 350 cells/mm3 will be excluded from the trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aurum Institute - Tembisa Clinical Research Centre
Tembisa, Gauteng, 1632, South Africa
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Perinatal HIV Research Unit Tshepong Hospital Complex
Klerksdorp, 2574, South Africa
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Setshaba Research Center
Pretoria, 0152, South Africa
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TASK Applied Science, Brooklyn Chest Hospital Premises
Cape Town, 7100, South Africa
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Themba Lethu Clinic Clinical HIV Research Unit (CHRU)
Johannesburg, 2092, South Africa
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University of CapeTown Lung Center Institute
Cape Town, 7700, South Africa
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