Short-Course Regimen With Bedaquiline, Moxifloxacin and Pyrazinamide for Early Bactericidal Activity in Drug-Susceptible Tuberculosis

Launched by SHANGHAI PULMONARY HOSPITAL, SHANGHAI, CHINA · Aug 18, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a shorter treatment for people with drug-susceptible pulmonary tuberculosis (TB), which means TB that can be treated with standard medicines. The study is looking at how well a 4-month treatment using a combination of three drugs—bedaquiline, moxifloxacin, and pyrazinamide—works to kill TB bacteria early on, compared to the usual 6-month treatment. Researchers also want to see if this shorter treatment is safe and well-tolerated. The goal is to find a faster, effective treatment that could help patients finish their medicine more easily and improve recovery.

Adults between 18 and 60 years old with confirmed drug-susceptible TB who can produce enough sputum (mucus from the lungs) for testing may be eligible. Participants will be randomly assigned to receive either one of two 4-month drug combinations or the standard 6-month treatment. During the study, patients will have regular check-ups to monitor how quickly the bacteria are being killed, how their bodies respond to the drugs, and whether they experience any side effects. Pregnant women, people with other serious health issues, or those with drug-resistant TB are not eligible. This trial hopes to offer better treatment options for TB patients in the future.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years and ≤60 years
• • 2. Male or female
• • 3. Body weight 40-90 kg
• • 4. Capable of producing adequate sputum, with collection of at least 10ml overnight sputum
• • 5. Willing to participate in trial treatment and follow-up, with signed informed consent (legal guardian may sign for patients lacking civil capacity)
• • 6. Positive acid-fast bacilli smear microscopy of respiratory specimens (≥1+ according to WHO criteria) and positive rapid amplification test for Mycobacterium tuberculosis in respiratory specimens
• • 7. Rifampicin-susceptible based on molecular drug susceptibility testing or conventional drug susceptibility testing
• • 8. No anti-TB treatment for more than 3 days received within 6 months before the screening period
• • 9. Subjects whose imaging findings meet the diagnostic criteria for TB, as determined by the investigator
• • 10. Women of childbearing potential who have not undergone surgical sterilization must agree to use appropriate contraceptive methods
• Exclusion Criteria:
• • 1. Evidence of concurrent extrapulmonary TB
• • 2. Subjects who have participated in other clinical studies within 8 weeks before the screening period
• • 3. Confirmed resistance of mycobacterium tuberculosis isolates to any of the following: Isoniazid, fluoroquinolones, revealed by molecular drug susceptibility testing
• • 4. Known allergy or intolerance to any study drug
• • 5. Patients who cannot receive oral therapy
• • 6. Abnormal liver function (alanine transaminase \[ALT\], alkaline phosphatase \[ALP\], or total bilirubin \[TBil\] exceeding 2 times the upper limit of normal) or known cirrhosis or known alcoholic hepatitis
• • 7. The hematology indicates white blood cells \<3.0×10⁹/L, or hemoglobin \<80 g/L, or platelets \<80×10⁹/L
• • 8. The estimated glomerular filtration rate (eGFR) is less than 60 mL/min/1.73 m²
• • 9. The blood electrolyte test indicates a baseline serum potassium level less than 3.5 mmol/L
• • 10. Subjects who have used drugs known to prolong the QTcF interval for more than 3 days within 30 days before the screening period (including but not limited to amiodarone, bisoprolol, chloroquine, chlorpromazine, cisapride, cyclobenzaprine, clarithromycin, digoxin, dofetilide, domperidone, ertapenem, ibutilide, levomethadone, methadone, pentamidine, quinidine, sotalol, sparfloxacin, thioridazine)
• • 11. Subjects with clinically significant ECG abnormalities as determined by the investigator, including but not limited to: baseline QTcF \>450 ms for males or \>470 ms for females, presence of second- or third-degree atrioventricular block, QRS duration \>120 ms
• • 12. Combined heart failure, coronary artery disease, myocardial infarction, ventricular hypertrophy, clinically significant arrhythmia, poorly controlled hypertension-related cardiovascular disease
• • 13. Patients with known QT prolongation syndrome or a family history thereof
• • 14. Subjects who have used any drug or substance known to be a strong inhibitor of cytochrome P450 enzymes within 30 days before the screening period (including but not limited to ritonavir, ketoconazole, itraconazole, voriconazole, clarithromycin, fluvoxamine, warfarin, rivaroxaban, and other novel oral anticoagulants)
• • 15. Subjects with known bleeding disorders or family history of bleeding disorders
• • 16. Subjects with HIV infection
• • 17. Subjects with known optic neuritis, history of alcoholism, gout, epilepsy, mental illness, porphyria, myasthenia gravis, or malignant tumors
• • 18. Patients with type I or type II diabetes, or HbA1c ≥6.5%, or random blood glucose ≥11.1 mmol/L with typical diabetic symptoms
• • 19. Pregnant or lactating patients