Short-Course Regimen With Bedaquiline, Moxifloxacin and Pyrazinamide for Early Bactericidal Activ… (NCT07129629) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Short-Course Regimen With Bedaquiline, Moxifloxacin and Pyrazinamide for Early Bactericidal Activity in Drug-Susceptible Tuberculosis
45 participantsStarted 2025-08-20
Plain-language summary
\# Brief Summary
This study aims to evaluate the early bactericidal activity (EBA), safety, and tolerability of 4-month short-course regimens containing bedaquiline, moxifloxacin, and pyrazinamide in patients with drug-susceptible tuberculosis. This is a prospective, randomized, controlled, multicenter study planned to enroll 45 rifampicin-susceptible tuberculosis patients, who will be randomized in a 1:1:1 ratio to the BZMD group (bedaquiline + pyrazinamide + moxifloxacin + delamanid), BZMH group (bedaquiline + pyrazinamide + moxifloxacin + isoniazid), and standard control group. Subjects in the test groups will receive 17 weeks (4 months) of group-specific treatment regimens, while subjects in the control group will receive 26 weeks (6 months) of standard HRZE regimen treatment.
The primary endpoint is the change from baseline in log₁₀ colony-forming units (CFU) per milliliter of sputum specimen from Day 0 (pre-dose) to Day 14 of treatment (EBA CFU₀-₁₄), used to evaluate the early bactericidal activity of the drugs. Secondary endpoints include EBA CFU and EBA TTP (time to positive culture) at other time intervals, pharmacokinetic characteristics, sustained microbiological clearance rates, relapse rates, and safety indicators. The study will analyze the daily decline in log₁₀ CFU counts and daily increase in TTP using nonlinear mixed-effects models to reflect the bactericidal activity of the study regimens.
This study will help provide more effective and safer short-course treatment options for Chinese patients with drug-susceptible tuberculosis, thereby improving treatment adherence and treatment success rates, and providing scientific evidence for optimizing short-course treatment regimens for drug-susceptible tuberculosis.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥18 years and ≤60 years
✓. Male or female
✓. Body weight 40-90 kg
✓. Capable of producing adequate sputum, with collection of at least 10ml overnight sputum
✓. Willing to participate in trial treatment and follow-up, with signed informed consent (legal guardian may sign for patients lacking civil capacity)
✓. 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
✓. Rifampicin-susceptible based on molecular drug susceptibility testing or conventional drug susceptibility testing
✓. No anti-TB treatment for more than 3 days received within 6 months before the screening period
Exclusion criteria
✕. Evidence of concurrent extrapulmonary TB
What they're measuring
1
Early Bactericidal Activity CFU 0-14 (EBA CFU₀-₁₄)
Timeframe: Day 0 (baseline) to Day 14 of treatment
Trial details
NCT IDNCT07129629
SponsorShanghai Pulmonary Hospital, Shanghai, China
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-12-31
Contact for this trial
sha wei Chief Physician and Doctoral Supervisor, MD&PhD
. Subjects who have participated in other clinical studies within 8 weeks before the screening period
✕. Confirmed resistance of mycobacterium tuberculosis isolates to any of the following: Isoniazid, fluoroquinolones, revealed by molecular drug susceptibility testing
✕. Known allergy or intolerance to any study drug
✕. Patients who cannot receive oral therapy
✕. 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
✕. The hematology indicates white blood cells \<3.0×10⁹/L, or hemoglobin \<80 g/L, or platelets \<80×10⁹/L
✕. The estimated glomerular filtration rate (eGFR) is less than 60 mL/min/1.73 m²