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| Name | Class |
|---|---|
| Beijing Chest Hospital | OTHER |
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This is an investigational, prospective, multicenter, single-arm, open label trial. The goal of this clinical trial is to evaluate the efficacy and safety of a 6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) or Clofazimine (CFZ, C), or BDLLfxC regimen, to treat rifampin-resistant pulmonary tuberculosis (RR-TB) in Chinese teenagers and adults (aged 12 years or above). The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BDLL | Experimental | 6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) or Clofazimine (CFZ, C), as known as BDLLfxC or BDLL regimen |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bedaquiline | Drug | 400 milligrams (mg) daily for 2 weeks(w), then 200mg three times a week for 22 weeks (w) |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with favorable outcomes in both treatment and follow-up period | Favorable outcome in treatment period (up to 28 weeks after start of treatment): a participant's outcome will be defined as "favorable" if it meets any of the following below and has not been defined as "unfavorable" before,
(1). Cured: sputum culture negative at 72 weeks from start of treatment; (2). Culture negative when last seen: loss to follow-up before 72 weeks, with negative sputum culture when last seen. | Up to 72 weeks after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with grade 3 or 4 adverse effect | Adverse effect will be graded using Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. | Up to 72 weeks after start of treatment |
| Proportion of participants with favorable outcomes in treatment period, follow-up period and prolonged follow-up period, respectively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Chest Hospital | Hefei | Anhui | China | |||
| The 8th Medical Center of Chinese PLA General Hospital |
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| delamanid | Drug |
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| linezolid | Drug |
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| Levofloxacin | Drug | Only for participants with confirmed fluoroquinolone-susceptible TB or unknown fluoroquinolone susceptibility:
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| Clofazimine | Drug | Only for participants with confirmed fluoroquinolone-resistant TB or unknown fluoroquinolone susceptibility: 100mg daily, for 24w if a negative culture is obtained from sputum collected at 16w, or else for 36w |
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The definitions of favorable outcome in treatment and follow-up period are as described in primary outcome. Favorable outcome in prolonged follow-up period (from end of treatment to 108 weeks after start of treatment): a participant's outcome will be defined as "favorable" if it meets any of the following below and has not been defined as "unfavorable" before, (1). Cured: sputum culture negative at 108 weeks from start of treatment; (2). Culture negative when last seen: loss to follow-up before 108 weeks, with negative sputum culture when last seen. |
| Up to 108 weeks after start of treatment |
| Time to culture conversion | Time from start of treatment to the first time that obtained two consecutive negative sputum culture results, and the sputum samples must be collected 14 days apart. The date when first sputum sample is collected will be recorded as the date for culture conversion. | Up to 72 weeks after start of treatment |
| Beijing |
| Beijing Municipality |
| China |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | China |
| The Fourth People's Hospital of Nanning | Nanning | Guangxi | China |
| Liupanshui Third People's Hospital | Liupanshui | Guizhou | China |
| Hebei Chest Hospital | Shijiazhuang | Hebei | China |
| The Fifth Hospital of Shijiazhuang | Shijiazhuang | Hebei | China |
| Infectious Disease Hospital of Heilongjiang Province | Harbin | Heilongjiang | China |
| Jiamusi Tuberculosis Hospital(Jiamusi Cancer Hospital) | Jiamusi | Heilongjiang | China |
| Harbin Chest Hospital | Harbin | Helongjiang | China |
| Luoyang Center Hospital | Luoyang | Henan | China |
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan | China |
| Henan Chest Hospital | Zhengzhou | Henan | China |
| Henan Infectious Disease Hospital | Zhengzhou | Henan | China |
| Wuhan Pulmonary Hospital,Wuhan Tuberculosis Prevention and Control Institute | Wuhan | Hubei | China |
| Changsha Central Hospital | Changsha | Hunan | China |
| Hulunbuir Infectious Disease Hospital | Hulunbuir | Inner Mongolia | China |
| The Second Hospital of Nanjing | Nanjing | Jiangsu | China |
| Jiangxi Chest Hospital | Nanchang | Jiangxi | China |
| Infectious Disease Hospital of Changchun | Changchun | Jilin | China |
| Jilin Tuberculosis Hospital | Jilin City | Jilin | China |
| Shenyang Chest Hospital | Shenyang | Liaoning | China |
| Xi'an Chest Hospital | Xi'an | Shaanxi | China |
| Shandong Public Health Clinical Center, Shandong University | Jinan | Shandong | China |
| Linyi People Hospital | Linyi | Shandong | China |
| Qingdao Chest Hospital | Qingdao | Shandong | China |
| Weifang No.2 People's Hospital | Weifang | Shandong | China |
| Yantai Qishan Hospital | Yantai | Shandong | China |
| Shanxi Medical University Affiliated Chest Hospital | Taiyuan | Shanxi | China |
| Public Health Clinical Center of Chengdu | Chengdu | Sichuan | China |
| Tianjin Haihe Hospital | Tianjin | Tianjin Municipality | China |
| Wenzhou Central Hospital | Wenzhou | Zhejiang | China |
| Beijing Chest Hospital | Beijing | China |
| Huashan Hospital | Shanghai | China |
| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| D014397 | Tuberculosis, Pulmonary |
| 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 |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C493870 | bedaquiline |
| C516022 | OPC-67683 |
| C007792 | Fumigant 93 |
| D000069349 | Linezolid |
| D064704 | Levofloxacin |
| D002991 | Clofazimine |
| ID | Term |
|---|---|
| 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 |
| D006571 | Heterocyclic Compounds |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010619 | Phenazines |
| D006575 | Heterocyclic Compounds, 3-Ring |
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