Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New 9-Month pill regimen could tackle Drug-Resistant TB

NCT ID NCT07268664

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

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

12 years and older

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Drug-resistant tuberculosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Center of Disease Prevention and Control in Kashi Area

    Kashgar, Xinjiang, China

  • Hetian Prefecture Infectious Diseases Hospital

    Hetian, Xinjiang, China

  • The Third People's Hospital in Aksou

    Aksu, Xinjiang, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.