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| ID | Type | Description | Link |
|---|---|---|---|
| TMC207TBC4006 | Other Identifier | Janssen Research & Development LLC |
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The purpose of this study is to evaluate efficacy and safety of an oral bedaquiline-containing multidrug-resistant tuberculosis (MDR-TB) short-course regimen (SCR) compared to an oral SCR not including bedaquiline at the end of treatment in participants with pulmonary MDR-TB in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bedaquiline-containing Short-course Regimen (SCR) | Experimental | Participants will receive an oral dose of bedaquiline 400 milligrams (mg) once daily for first 2 weeks followed by bedaquiline 200 mg thrice a week for 22 weeks (with at least 48 hours between doses) in combination with oral doses of levofloxacin (LFX) up to 1000 mg (weight-based), cycloserine (CS) up to 750 mg (weight-based), clofazimine (CFZ) 100 mg daily for 40 weeks and linezolid [LZD] 600 mg daily for at least 24 weeks . If a participant is still sputum culture-positive for Mycobacterium tuberculosis by Week 16, bedaquiline treatment will be extended from Week 24 to Week 40. |
|
| Non-bedaquiline-containing Short-course Regimen (SCR) | Experimental | Participants will receive oral doses of LFX up to 1000 mg (weight-based), CS up to 750 mg (weight-based), CFZ 100 mg, Pyrazinamide (PZA) up to 2000 mg (weight-based), Protionamide (PTO) up to 800 mg (weight-based) daily for first 16 weeks and LZD 600 mg daily for at least 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bedaquiline | Drug | Bedaquiline uncoated tablets will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with a Favorable Treatment Outcome at the End of Treatment | Percentage of participants with a favorable treatment outcome at the end of treatment will be reported. A participant's outcome will be classified as favorable if their last 3 culture results by the end of treatment are negative unless they have previously been classified as unfavorable. These 3 cultures must be taken on separate visits; the latest of which being no more than 8 weeks prior to the end of treatment. | At the end of treatment (Week 40) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with a Favorable Treatment Outcome at 48 Weeks Post the End of Treatment | Percentage of participants with a favorable treatment outcome at 48 weeks post the end of treatment will be reported. A participant's outcome will be classified as favorable if their last 3 culture results by the end of treatment are negative unless they have previously been classified as unfavorable. These 3 cultures must be taken on separate visits; the latest of which being no more than 8 weeks prior to the end of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingtao Gao, PhD | Contact | +8610-89509131 | jingtaogao@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Mengqiu Gao | Beijing Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chest Hospital | Recruiting | Beijing | 101149 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41925982 | Derived | Gao J, Huang Z, Ren F, Wu Y, Wang H, Wu G, Du J, Yan X, Pei Y, Jin L, Xiong Y, Shi L, Cui J, Chen X, Li X, Sha W, An H, Callewaert K, Lounis N, Bakare N, Jiang Y, Zhang R, Wang L, Gao M, Li L. Evaluation of an oral bedaquiline regimen for treating multidrug-resistant TB in China: a randomized trial. Infection. 2026 Jun;54(3):1265-1277. doi: 10.1007/s15010-026-02734-w. Epub 2026 Apr 2. | |
| 38561815 |
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| Levofloxacin | Drug | Levofloxacin filmcoated will be administered orally |
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| Linezolid | Drug | Linezolid tablets will be administered orally |
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| Cycloserine | Drug | Cycloserine capsules will be administered orally. |
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| Clofazimine | Drug | Clofazimine capsules will be administered orally. |
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| Pyrazinamide | Drug | Pyrazinamide tablets will be administered orally. |
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| Protionamide | Drug | Protionamide enteric-coated tablets will be administered orally. |
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| At 48 weeks post the end of treatment (Week 88) |
| Percentage of Participants Achieving Treatment Success at the end of Treatment | Percentage of participants achieving treatment success at the end of treatment will be reported. Treatment success is achieved if participants completed their prescribed tuberculosis (TB) treatment; or if their last 3 culture results are negative by the end of treatment, these 3 cultures must be taken on separate visits and should be after the initial 6-month treatment period. | At the end of treatment (Week 40) |
| Percentage of Participants with a Modified Favorable Treatment Outcome at the end of Treatment and at 48 Weeks Post end of Treatment | Percentage of participants with a modified favorable treatment outcome at the end of treatment and at 48 weeks post end of treatment will be reported. A participant's treatment outcome will be classified as modified favorable if their last 2 culture results by the end of treatment are negative unless they have previously been classified as unfavorable. These 2 cultures must be taken on separate visits; the latest of which being no more than 8 weeks prior to the end of treatment. | At the end of treatment (Week 40) and at 48 weeks post end of treatment (Week 88) |
| Percentage of Participants Experiencing All-cause Mortality | Percentage of participants experiencing all-cause mortality will be reported. | Up to Week 88 |
| Percentage of Participants Experiencing Grade 3 or Greater Treatment-emergent Adverse Events (TEAEs) During Study Treatment and Follow-up | Percentage of participants experiencing grade 3 or greater TEAEs during study treatment and follow-up will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as any event that begins or worsens in severity after initiation of study drug through to the end of study. An assessment of severity grade will be made using the following 5 general categorical descriptors based on division of acquired immunodeficiency syndrome (AIDS) grading for AE severity assessment. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death. | During study treatment and follow-up (From Week 1 up to Week 88) |
| Percentage of Participants Experiencing TEAEs | Percentage of participants experiencing TEAEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as any event that begins or worsens in severity after initiation of study drug through to the end of study. | From Week 1 up to Week 88 |
| Percentage of Participants with TB Relapses and Re-infections During the Treatment-free Follow-up Phase | Percentage of participants with TB relapses and re-infections during the treatment-free follow-up phase will be reported. | During the treatment-free follow-up phase (Up to 48 weeks) |
| Percentage of Participants Whose Isolates Develop Resistance to Bedaquiline and Other Drugs Used in the Regimen | Percentage of participants whose isolates develop resistance to bedaquiline and other drugs used in the regimen will be reported. | Up to Week 88 |
| The Eighth Medical Center of PLA General Hospital | Recruiting | Beijing | China |
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| Changsha Central Hospital | Recruiting | Changsha | China |
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| Public health clinical medical center of Chengdu | Recruiting | Chengdu | China |
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| Chongqing Public Health Medical Center | Recruiting | Chongqing | China |
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| The Pulmonary Hospital of Fuzhou in Fujian Provinceļ¼The tuberculosis control and prevention Hospital of Fuzhou in Fujian Provinceļ¼ | Recruiting | Fuzhou | China |
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| Guiyang Public Health Clinical Center | Recruiting | Guiyang | China |
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| Anhui Chest Hospital | Recruiting | Hefei | China |
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| Infectious Disease Hospital of Heilongjiang Province | Recruiting | Heilongjiang | China |
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| Jiamusi Tumor Hospital | Not yet recruiting | Jiamusi | China |
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| Jiangxi Chest Hospital | Not yet recruiting | Jiangxi | China |
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| Shandong public health clinical center | Recruiting | Shandong | China |
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| Shanghai Pulmonary Hospital | Recruiting | Shanghai | China |
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| Shenyang Chest Hospital | Recruiting | Shenyang | China |
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| Wuhan Pulmonary Hospital | Recruiting | Wuhan | China |
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| Xi'an Chest Hospital | Recruiting | Xi'an | China |
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| The First Affiliated Hospital of Xinxiang Medical University | Recruiting | Xinxiang | China |
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| Derived |
| Gao J, Gao M, Du J, Pang Y, Mao G, Lounis N, Bakare N, Jiang Y, Zhan Y, Liu Y, Li L; Trial Team. A pragmatic randomized controlled trial to evaluate the efficacy and safety of an oral short-course regimen including bedaquiline for the treatment of patients with multidrug-resistant tuberculosis in China: study protocol for PROSPECT. Trials. 2024 Apr 1;25(1):227. doi: 10.1186/s13063-024-07946-9. |
| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C493870 | bedaquiline |
| D064704 | Levofloxacin |
| D000069349 | Linezolid |
| D003523 | Cycloserine |
| D002991 | Clofazimine |
| D011718 | Pyrazinamide |
| D011515 | Prothionamide |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D007555 | Isoxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010619 | Phenazines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011719 | Pyrazines |
| D007539 | Isonicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
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