A Phase 2 interventional study of Bedaquiline (B) and Moxifloxacin in Tuberculosis, Pulmonary and Drug-Susceptible Pulmonary Tuberculosis, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Phase 2, Interventional, and Treatment
# 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.
Study Background and Rationale Tuberculosis remains a significant global health challenge, with China ranking among the top three countries with the highest TB burden globally. Current anti-TB treatments for drug-susceptible tuberculosis face major obstacles, primarily poor adherence to long-term (at least 6 months) and complex treatment regimens. Incomplete TB treatment may lead to increased morbidity and mortality, prolonged infectivity, and development of drug resistance.
Recent international studies have demonstrated promising results for shorter treatment regimens. The SimpliciTB study showed that a 4-month short-course regimen containing bedaquiline, moxifloxacin, and pyrazinamide significantly increased 8-week sputum culture clearance rates compared to the standard 6-month regimen. The TRUNCATE-TB study demonstrated that a 2-month regimen containing bedaquiline, isoniazid, and pyrazinamide was non-inferior to standard 6-month treatment. However, bedaquiline-based 4-month short-course regimens have not yet been validated in early-stage studies in the Chinese population.
Study Methodology Treatment Regimens
BZMD Group (Total treatment: 17 weeks):
Intensive phase (8 weeks): Bedaquiline + Pyrazinamide + Moxifloxacin + Delamanid Consolidation phase (9 weeks): Bedaquiline + Moxifloxacin + Delamanid Bedaquiline: 400 mg once daily for 2 weeks, then 200 mg three times weekly for weeks 3-17 Pyrazinamide: Weight-based dosing (1000-2000 mg daily) - intensive phase only Moxifloxacin: 400 mg once daily throughout treatment Delamanid: 100 mg twice daily (200 mg total daily) throughout treatment
BZMH Group (Total treatment: 17 weeks):
Intensive phase (8 weeks): Bedaquiline + Pyrazinamide + Moxifloxacin + Isoniazid Consolidation phase (9 weeks): Bedaquiline + Moxifloxacin + Isoniazid Bedaquiline: Same dosing as BZMD group Pyrazinamide: Weight-based dosing - intensive phase only Moxifloxacin: 400 mg once daily throughout treatment Isoniazid: 300 mg once daily throughout treatment
Standard Control Group (Total treatment: 26 weeks):
Intensive phase (8 weeks): Rifampicin + Isoniazid + Pyrazinamide + Ethambutol Consolidation phase (18 weeks): Rifampicin + Isoniazid
Early Bactericidal Activity Assessment The study employs a rigorous EBA assessment protocol with overnight sputum collections. Subjects must provide at least 10 mL of overnight sputum during each collection cycle. Two pre-treatment overnight sputum specimens are collected on consecutive days before treatment initiation to establish baseline CFU counts. Daily overnight sputum collections continue for the first 14 days of treatment to monitor bactericidal activity.
Pharmacokinetic Substudy A subset of subjects (10-15 per test group) will participate in intensive PK sampling on Day 14, involving 11 blood draws over 24 hours to evaluate steady-state pharmacokinetic characteristics and potential drug-drug interactions between study medications.
Follow-up and Retreatment Criteria All subjects are followed until week 38 post-treatment initiation. For test group subjects who fail to achieve sustained microbiological clearance at end of treatment (week 17) or experience recurrence during follow-up, a standard 6-month HRZE regimen will be re-initiated.
Quality Control Measures
The study implements comprehensive quality assurance including:
Statistical Considerations Bactericidal activity will be analyzed using nonlinear mixed-effects models to estimate daily log₁₀ CFU reduction and TTP increases. The study design allows for replacement of subjects who cannot provide adequate sputum specimens to ensure statistical precision. Pharmacokinetic parameters will be compared between test groups using nonparametric methods.
Clinical Significance This study addresses a critical need in tuberculosis treatment by evaluating whether bedaquiline-based short-course regimens can reduce treatment duration from 6 months to 4 months while maintaining efficacy. Successful results could lead to improved treatment adherence, reduced healthcare costs, and decreased risk of drug resistance development. The study specifically focuses on the Chinese population, addressing potential pharmacokinetic and genetic variations that may influence treatment outcomes.
The early bactericidal activity endpoint provides rapid assessment of regimen efficacy, allowing for early identification of promising combinations before larger, longer-term studies. This approach accelerates the development of improved tuberculosis treatment regimens while maintaining rigorous safety monitoring.
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
This study's planned enrollment of 45 is below the median of 146 across 227 interventional studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 160 studies on the registry; 95 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
4-month short-course regimen. Intensive phase (8 weeks): Bedaquiline + Pyrazinamide + Moxifloxacin + Delamanid. Consolidation phase (9 weeks): Bedaquiline + Moxifloxacin + Delamanid. Total treatment duration 17 weeks followed by follow-up until week 38.
Drug: Bedaquiline (B) · Drug: Moxifloxacin · Drug: Pyrazinamide (PZA) · Drug: Delamanid (D)
4-month short-course regimen. Intensive phase (8 weeks): Bedaquiline + Pyrazinamide + Moxifloxacin + Isoniazid. Consolidation phase (9 weeks): Bedaquiline + Moxifloxacin + Isoniazid. Total treatment duration 17 weeks followed by follow-up until week 38.
Drug: Bedaquiline (B) · Drug: Moxifloxacin · Drug: Pyrazinamide (PZA) · Drug: Isoniazid (H)
Standard 6-month regimen. Intensive phase (8 weeks): Rifampicin + Isoniazid + Pyrazinamide + Ethambutol. Consolidation phase (18 weeks): Rifampicin + Isoniazid. Total treatment duration 26 weeks followed by follow-up until week 38.
Drug: Pyrazinamide (PZA) · Drug: Isoniazid (H) · Drug: Rifampicin (R) · Drug: Ethambutol (E)
Bedaquiline tablets administered orally. Dosing: 400 mg once daily for the first 2 weeks, then 200 mg three times per week for weeks 3-17. Used in both experimental arms (BZMD and BZMH groups) as part of the 4-month short-course regimen for drug-susceptible tuberculosis treatment.
Also known as: BDQ
Moxifloxacin 400 mg tablets administered orally once daily before or after meals throughout the entire treatment period (17 weeks). Used in both experimental arms (BZMD and BZMH groups) as part of the 4-month short-course regimen for drug-susceptible tuberculosis treatment.
Also known as: Mfx
Pyrazinamide tablets administered orally once daily in the morning during intensive phase (8 weeks). Dosing by weight: 1000 mg for 40.0-49.9 kg, 1500 mg for 50.0-70.9 kg, 2000 mg for ≥75.0 kg. Used in both experimental arms (BZMD and BZMH groups) and control group as part of tuberculosis treatment regimen.
Also known as: PZA
Delamanid tablets administered orally at 100 mg twice daily (total daily dose 200 mg) throughout the entire treatment period (17 weeks). Used only in the BZMD experimental arm as part of the 4-month short-course regimen for drug-susceptible tuberculosis treatment.
Also known as: Dlm
Isoniazid tablets administered orally at 300 mg once daily in the morning throughout the entire treatment period. Used in the BZMH experimental arm (17 weeks) and in the standard control group (26 weeks) as part of tuberculosis treatment regimens.
Also known as: INH
Rifampicin tablets administered orally once daily in the morning throughout the entire treatment period (26 weeks). Dosing by weight: 450 mg for 40.0-49.9 kg, 600 mg for 50.0-70.9 kg and ≥75.0 kg. Used only in the standard control group as part of the 6-month standard tuberculosis treatment regimen.
Also known as: Rif
Ethambutol tablets administered orally during the intensive phase (8 weeks). Dosing by weight: 750 mg for 40.0-49.9 kg, 1000 mg for 50.0-70.9 kg and ≥75.0 kg. Used only in the standard control group as part of the 6-month standard tuberculosis treatment regimen.
Also known as: Emb
Early Bactericidal Activity CFU 0-14 (EBA CFU₀-₁₄)
The change from baseline in log10 colony-forming units (CFU) per milliliter of sputum specimen from baseline (Day 0, pre-dose) to Day 14 of treatment. This measures the early bactericidal activity of the drug regimens over the first 14 days of treatment.
Time frame: Day 0 (baseline) to Day 14 of treatment
Early Bactericidal Activity CFU 0-2 (EBA CFU₀-₂)
The change from baseline in log10 CFU per milliliter of sputum specimen from baseline to Day 2 of treatment.
Time frame: Day 0 to Day 2
Early Bactericidal Activity CFU 0-7 (EBA CFU₀-₇)
The change from baseline in log10 CFU per milliliter of sputum specimen from baseline to Day 7 of treatment.
Time frame: Day 0 to Day 7
Early Bactericidal Activity TTP 0-14 (EBA TTP₀-₁₄)
The daily change from baseline in time to positive culture (TTP, in hours) from baseline (Day 0, pre-dose) to Day 14 of treatment. This measures the early bactericidal activity by evaluating the extension in time required for bacterial culture to become positive.
Time frame: Day 0 (baseline) to Day 14 of treatment
Sustained Microbiological Clearance Rate
The sustained microbiological clearance rate at the end of 17 weeks of treatment in the test groups and control group. Defined as at least two consecutive negative culture results from respiratory specimens after baseline, with an interval of ≥14 days between specimen collection dates.
Time frame: Week 17 (end of treatment)
Safety - Grade 3 or Higher Adverse Events
Occurrence of Grade 3 or above adverse events according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) criteria during the study period.
Time frame: From enrollment through study completion, up to 52 weeks
Early Bactericidal Activity CFU 7-14 (EBA CFU₇-₁₄)
The change from baseline in log10 colony-forming units (CFU) per milliliter of sputum specimen from Day 7 to Day 14 of treatment. This measures the bactericidal activity during the second week of treatment.
Time frame: Day 7 to Day 14 of treatment
Early Bactericidal Activity TTP 0-2 (EBA TTP₀-₂)
The daily change from baseline in time to positive culture (TTP, in hours) from baseline (Day 0, pre-dose) to Day 2 of treatment. This measures the very early bactericidal activity within the first 2 days of treatment.
Time frame: Day 0 (baseline) to Day 2 of treatment
Early Bactericidal Activity TTP 0-7 (EBA TTP₀-₇)
The daily change from baseline in time to positive culture (TTP, in hours) from baseline (Day 0, pre-dose) to Day 7 of treatment. This measures the early bactericidal activity during the first week of treatment.
Time frame: Day 0 (baseline) to Day 7 of treatment
Early Bactericidal Activity TTP 7-14 (EBA TTP₇-₁₄)
The daily change from baseline in time to positive culture (TTP, in hours) from Day 7 to Day 14 of treatment. This measures the bactericidal activity during the second week of treatment by evaluating changes in time to culture positivity.
Time frame: Day 7 to Day 14 of treatment
Relapse Rate
The relapse rate in the test groups and control group at the end of the follow-up phase. Relapse is defined as subjects who had previously received anti-TB treatment in the regimen, were judged as cured or completed treatment at the end of treatment, and are now diagnosed with tuberculosis (whether relapse or reinfection).
Time frame: Up to Week 52 (end of follow-up phase)
AUC₀-₂₄ of Anti-TB Drugs
Area under the concentration-time curve from 0 to 24 hours (AUC₀-₂₄) at steady-state for Bedaquiline, Moxifloxacin, Pyrazinamide, Delamanid, and Isoniazid.
Time frame: Day 14 (24-hour intensive sampling)
Cmax of Anti-TB Drugs
Maximum plasma concentration at steady-state (Cₘₐₓ,ₛₛ) for Bedaquiline, Moxifloxacin, Pyrazinamide, Delamanid, and Isoniazid.
Time frame: Day 14 (24-hour intensive sampling)
Adverse Drug Reactions
Occurrence of adverse drug reactions (ADRs) that are determined to be related to the study medications. ADRs are defined as adverse events with evidence of reasonable temporal relationship with study drug use and more likely attributable to the study drug than to other causes.
Time frame: From enrollment through study completion, up to 52 weeks
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in this study will be shared, including: Efficacy data: Early bactericidal activity measurements (CFU counts, time to positive culture), sustained microbiological clearance rates, and relapse rates Safety data: Adverse events, serious adverse events, laboratory values, and vital signs Pharmacokinetic data: Drug concentration measurements and calculated PK parameters for participants who consented to PK sampling Demographic and baseline characteristics: Age, sex, body weight, baseline disease characteristics, and medical history Treatment data: Drug dosing, treatment duration, adherence, and treatment modifications Data will be shared after de-identification and removal of all direct and indirect identifiers. The study protocol, statistical analysis plan, informed consent form, and clinical study report will also be made available.
Start is estimated for Aug 2025; primary completion for Dec 2026, 16 months later.
Of 33 non-industry phase 2 interventional studies under Tuberculosis, Pulmonary, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 49. This study's planned 16 months is below that.
Counting every sponsor, half of 43 studies reached it within 30 months; a quarter within 21 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Bedaquiline · Moxifloxacin
Shanghai Pulmonary Hospital, Shanghai, China →