New 9-Month pill regimen could tackle Drug-Resistant TB
NCT ID NCT07268664
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests a 9-month, all-oral combination of four drugs (BLMZ) for people aged 12 and older with rifampicin-resistant tuberculosis. The goal is to see if this shorter regimen leads to a cure without the need for injections. Participants take the pills daily or weekly and are followed for 24 months to check for safety and effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BLMZ regimen (Bedaquiline, Linezolid, Moxifloxacin/Levofloxacin, Pyrazinamide)
- What this could lead to
- If successful, this could provide a shorter, all-oral treatment option for rifampicin-resistant tuberculosis, potentially improving cure rates and reducing treatment burden.
- What could go wrong
- This is a single-arm trial with no comparison group, so results are compared to historical data. The regimen may cause side effects like nerve damage or liver issues, and it may not work for everyone.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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12 years and older
- 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: * The participant (and their guardian if the participant lacks civil capacity) voluntarily signs the informed consent form (ICF) prior to enrollment. * The participant (and their guardian) indicates willingness to complete all steps and intervention periods of the study. * Male or female, aged ≥12 years, with a body weight ≥30 kilograms (kg). * Bacteriologically confirmed pulmonary tuberculosis, with molecular or phenotypic drug susceptibility testing (DST) results within the last 3 months confirming Rifampicin resistance and susceptibility to at least one of Moxifloxacin (MFX) or Levofloxacin (LFX). * Sputum or respiratory lavage fluid collected during the screening period is culture-positive for Mycobacterium tuberculosis, with DST results indicating Rifampicin resistance and susceptibility to at least one of MFX or LFX. * Females of childbearing potential are not pregnant (as confirmed by a negative pregnancy test), voluntarily agree to pregnancy testing, and are willing to use highly effective contraception from the time of ICF signing until 3 months after the end of study treatment. * For males of reproductive potential, use condoms or other methods to ensure effective contraception for their partner. * Females who are breastfeeding are willing to discontinue breastfeeding from the time of ICF signing until 3 months after the end of study treatment. * Voluntary acceptance of HIV testing; if the result is positive, voluntary acceptance of antiretroviral therapy. Exclusion Criteria: * Previous treatment with any of the drugs Bedaquiline (BDQ) or Linezolid (LZD) for more than 30 days. * Concurrent hematogenous disseminated pulmonary tuberculosis or severe extrapulmonary tuberculosis as determined by the investigator. * Current use of medications prohibited by the study protocol, and the investigator judges that the priority of continuing said medication for patient benefit outweighs participation in this study. (Note: If the investigator judges that the benefit of participating in this study is higher and obtains the participant's consent, the prohibited medication should be discontinued with an adequate washout period before participation.) * Known history of hypersensitivity to any drug in the protocol. * Current participation in any other investigational drug clinical trial. * Presence of cardiovascular disease risk at screening: 1. QTcF interval \>450 milliseconds (ms). (Note: If QTcF \>450 ms is detected, one unscheduled visit during the screening period is allowed for re-assessment.) 2. History of clinically significant arrhythmia within 60 days prior to enrollment, which in the investigator's opinion may increase risk upon study participation. 3. Decompensated heart failure. 4. Grade 3 hypertension not at control target. 5. Abnormal thyroid function. 6. Abnormal serum calcium, magnesium, or potassium levels. (Note: Isolated electrolyte disturbances without underlying disease may be considered for re-screening after corrective treatment.) 7. Other conditions deemed by the investigator to pose a cardiovascular disease risk. * History of optic neuropathy or peripheral neuropathy, which in the investigator's opinion may progress/worsen during the study or is unsuitable for study participation. * Evidence of liver disease at screening: 1. Active viral hepatitis: Positive HBsAg, or positive HBeAg and HBV DNA, or positive HCV RNA test, accompanied by persistent or recurrent abnormal ALT. 2. Decompensated cirrhosis. * History of renal disease or renal disease-related manifestations at screening: 1. History of unstable or rapidly progressive renal disease. 2. Moderate/severe renal impairment or end-stage renal disease (eGFR \< 60 mL/min/1.73 m²). 3. Serum creatinine (Cr) ≥133 μmol/L (1.5 mg/dL) for males, or Cr ≥124 μmol/L (1.4 mg/dL) for females. * Other laboratory abnormalities at screening: 1. Hemoglobin level \< 8.0 g/dL. 2. Platelet count \<75,000 /mm³. 3. Absolute neutrophil count (ANC) \<1000 /mm³. 4. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \>3 times the upper limit of normal (ULN). 5. Total bilirubin \>2 times ULN, or \>1.5 times ULN accompanied by other abnormal liver enzymes. 6. Albumin \<30 g/L. * Pregnant or breastfeeding. * Any other condition (e.g., severe psychiatric disorder, neurological condition, substance abuse) that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to adhere to the protocol.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Center of Disease Prevention and Control in Kashi Area
Kashgar, Xinjiang, China
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Hetian Prefecture Infectious Diseases Hospital
Hetian, Xinjiang, China
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The Third People's Hospital in Aksou
Aksu, Xinjiang, China
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Other studies related to the condition(s) this trial covers.
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- Can starting TB treatment immediately save lives in HIV sepsis?
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