New 2-Month TB pill cocktail could replace 6-Month regimen
NCT ID NCT06905522
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new ultra-short treatment for both drug-sensitive and drug-resistant tuberculosis (TB). The goal is to see if a 2-3 month regimen works as well as or better than the standard 4-6 month treatment. About 610 adults with active TB will take part. The approach could simplify care, lower costs, and reduce side effects.
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 610 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2029
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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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. Age range from 18 to 65 years old, regardless of gender; 2. Clinical symptoms and/or pulmonary imaging (chest X-ray or chest CT) support the diagnosis of active pulmonary tuberculosis; 3. Microbiological testing (molecular or phenotypic) confirms the presence of Mycobacterium tuberculosis, whether resistant to rifampicin or not; Recommend using respiratory specimens for GeneXpert MTB/RIF testing; 4. Voluntarily sign the informed consent form for participating in this project and be able and willing to accept follow-up visits; 5. Willing to undergo HIV testing; 6. Willing to preserve samples including DNA; 7. For women with fertility, they have a negative serum or urine pregnancy test within 3 days before enroll the study and be willing to use effective contraceptive measures during the study period. Female subjects without fertility must have records of menopause, hysterectomy, bilateral oophorectomy, or bilateral tubal ligation. Acceptable forms of contraception include condoms, intrauterine devices, cervical caps with spermicides, and diaphragm with spermicides. Exclusion criteria: 1. Prior to this study, patients who were diagnosed with active pulmonary tuberculosis and had received anti-tuberculosis treatment (including first-line and second-line anti-tuberculosis drugs); 2. Intolerance or allergy to any investigational drug (i.e., bedaquiline, linezolid, fluoroquinolones \[including moxifloxacin, sitagliptin\], pyrazinamide); 3. Resistance to any investigational drug (i.e., bedaquiline, linezolid, fluoroquinolones \[including moxifloxacin, sitagliptin\], pyrazinamide). The following detection methods can be used: tNGS or other drug sensitivity testing methods (such as GeneXpert MTB/XDR, dissolution curve method, phenotypic drug sensitivity, etc.); 4. Suffering from hematogenous disseminated tuberculosis or coexisting with extrapulmonary tuberculosis (as specified in this study, the scope of pulmonary tuberculosis includes: simple pulmonary tuberculosis, pulmonary tuberculosis + tuberculous pleurisy/bronchial tuberculosis/mediastinal lymph node tuberculosis. Extrapulmonary tuberculosis refers to tuberculosis other than the chest-related types mentioned above); 5. Presence of non-tuberculous mycobacteria or other microbial lung infections that affect treatment outcomes; 6. Simultaneously using drugs that affect the efficacy of this study or have contraindications for combination therapy; 7. Use of any immunosuppressive medication or systemic glucocorticoids for more than 2 weeks before screening; 8. Any medication currently used or planned to be used that is known to significantly prolong the QTc interval, including but not limited to: amiodarone, amitriptyline, chloroquine, chlorpromazine, cisapride, dipyridamole, itraconazole, procaine, quinidine, or sotalol; 9. Uncontrolled blood sugar in diabetes, with no likelihood of improving blood sugar status according to the judgment of the researchers; 10. HIV positive; 11. Coexisting with severe autoimmune diseases, severe liver and kidney dysfunction, psychiatric disorders, hematological disorders, or malignant tumors; 12. Laboratory parameters within 14 days prior to recruitment: (1) Serum AST and ALT levels ≥ 3 times the upper limit of normal (ULN); (2) Blood creatinine ≥ 2 times ULN; (3) Hemoglobin ≤ 70 g/L; (4) Platelet count ≤ 50 × 10\^9/L; (5) Blood potassium levels are ≥ 5.5 mmol/L or ≤ 3.5 mmol/L; 13. ECG QTcF ≥450 ms (allowing for one re-test during the screening phase to reassess eligibility for inclusion); Presence of one or more risk factors that could cause QT interval prolongation, such as arrhythmia, myocardial ischemia, etc.; history or family history of long QT syndrome; 14. Women who are pregnant or breastfeeding; 15. Weight \<30 kg, or ≥90 kg; 16. The patient has participated in clinical trials of other drugs within the past 3 months during the screening period; 17. Other conditions deemed unsuitable for participation in the study by the research doctors.
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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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Beijing Chest Hospital of Capital Medical University
RECRUITINGBeijing, China
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Shenzhen Third People's Hospital
RECRUITINGShenzhen, China
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The Sixth People's Hospital of the Xinjiang Uygur Autonomous Region
RECRUITINGÜrümqi, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can simple sputum and urine tests catch tuberculosis earlier?
- A single swab, two diseases: rapid test takes on TB and COVID-19
- Can HIV status change TB treatment success? a zambian study investigates
- Beyond TB: could a deeper diagnostic look uncover hidden lung diseases?
- Can a new patient cohort unlock the secrets of TB treatment success?
- Shorter TB treatment: a 4-Month regimen put to the test