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| Name | Class |
|---|---|
| National Medical Center for Infectious Diseases | UNKNOWN |
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The goal of this clinical trial is to compare the efficacy and safety of a Contezolid and Delamanid-Containing short regimen to standard longer regimen in Rifampicin-resistant pulmonary tuberculosis (RR-TB). The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-Term Regimen | Experimental | Intervention will be determined based on Fluoroquinolones(FQs) resistance.
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| Standard Regimen | Active Comparator | Intervention will be determined based on Fluoroquinolones(FQs) resistance.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bedaquiline | Drug | Oral, 400mg qd for 2 weeks, then 200 mg 3 times per week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Favourable outcome rate at 24 months after randomization | The proportion of participants with a favourable outcome. A participant's outcome will be classified as favourable if their last two sputum culture results are negative unless they have previously been classified as unfavourable. These two cultures must be taken on separate visits (with ≥28d interval); the latest of which not being earlier than month 23 from randomization. | from randomization to 24 months after |
| Measure | Description | Time Frame |
|---|---|---|
| Unfavourable outcome rate at 24 months after randomization | Including
| from randomization to 24 months after |
| Time to culture conversion |
| Measure | Description | Time Frame |
|---|---|---|
| Contezolid plasma concentration | To build the population PK model of contezolid with steady-state plasma concentration, measured by blood samples taken at four time points around one administration: ≤15min before and 1h±15min, 2h±15min, 3h±15min after. The index adiministration should be in 7d±3d after the first dose of contezolid. | 7d±3d after the first dose of contezolid |
Inclusion criteria:
1) MTB positive in sputum or bronchoalveolar lavage fluid culture at or within 3 months before screening, or MTB positive in molecular test at or within 3 months before screening, and; 2) recorded Rifampicin-resistance at or before screening; 3. Imaging (Chest X-ray or CT scan) proved pulmonary tuberculosis within 1 year before screening; 4. Never used BDQ, DLM or CZD, or the accumulative duration of any of the treatment is not more than 2 weeks 5. For women in childbearing age, negative in pregnancy test and effective contraceptive measures throughout study is required; 6. For men, effective contraceptive measures is required; 7. Willing to participate the study and sign informed consent.
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chest Hospital affiliated to Capital Medical University | Beijing | Beijing Municipality | 101149 | China | ||
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| Delamanid | Drug | Oral, 100mg bid |
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| Contezolid | Drug | Oral, 800mg bid |
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| Levofloxacin | Drug | Oral, 400mg qd for weight <50kg, 600-750mg qd for weight ≥50kg |
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| Moxifloxacin | Drug | Oral, 400mg qd |
|
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| Clofazimine | Drug | Oral, 100mg qd |
|
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| Linezolid | Drug | Oral, 600mg qd |
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| Cycloserine | Drug | Oral, 250mg bid |
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| Prothionamide | Drug | Oral, 600mg qd for weight <50kg, 600-800mg qd for weight ≥50kg |
|
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| Pyrazinamide | Drug | Oral, 1500mg qd for weight <50kg, 1750mg qd for weight ≥50kg |
|
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| Para-Aminosalicylic Acid | Drug | 8000mg qd for weight <50kg, 10000mg qd for weight ≥50kg |
|
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| Ethambutol | Drug | 750mg qd for weight <50kg, 1000mg qd for weight ≥50kg |
|
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Time from treatment initiation to first negative result in sputum culture confirmed by two consecutive cultures with an interval of ≥28d |
| from randomization to 24 months after |
| Grade 3 or higher adverse event rate | Proportion of participants experiencing at least one grade 3 or higher adverse event, or serious adverse event defined by the Division of AIDS severity criteria for adverse events | from randomization to 24 months after |
| Changsha Central Hospital |
| Changsha |
| China |
| China |
| Anhui Chest Hospital | Hefei | China | China |
| Jiamusi Tumor Hospital | Jiamusi | China | China |
| Shandong public health clinical center | Shandong | China | China |
| Xi'an Chest Hospital | Xi'an | China | China |
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | China | China |
| Hebei Chest Hospital | Shijiazhuang | Hebei | 050000 | China |
| Harbin Chest Hospital | Harbin | Heilongjiang | 150000 | China |
| Infectious Disease Hospital of Hulunbuir | Hulunbuir | Inner Mongolia | China |
| Qingdao Chest Hospital | Qingdao | Shandong | 266000 | China |
| Taiyuan Fourth People's Hospital | Taiyuan | Shanxi | 030000 | China |
| The 8th Medical Center of Chinese Pla General Hospital | Beijing | China |
| Hunan Province Chest Hospital | Changsha | China |
| Chongqing Public Heath Treatment Center | Chongqing | China |
| Dalian Public Health Center | Dalian | China |
| Fuzhou Pulmonary Hospital of Fujian | Fuzhou | China |
| Guangzhou Chest Hospital | Guangzhou | China |
| Heilongjiang Province center for tuberculosis Control and Prevention | Haerbin | China |
| Second Affiliated Hospital of Hainan Medical University | Haikou | China |
| Hangzhou Red Cross Hospital | Hangzhou | China |
| Second People's Hospital of Hohhot | Hohhot | China |
| Jiamusi Infectious Disease Hospital | Jiamusi | China |
| Jilin Tuberculosis Hospital | Jilin City | China |
| People's Hospital of Linyi | Linyi | China |
| Second Hospital of Nanjing | Nanjing | China |
| Fourth People's Hospital of Nanning | Nanning | China |
| Guangxi Chest Hospital | Nanning | China |
| National Medical Center for Infectious Disease | Shanghai | China |
| Affiliated Hospital of Shaoxing University | Shaoxing | China |
| Shenyang Chest Hospital | Shenyang | China |
| Shijiazhuang Fifth Hospital | Shijiazhuang | China |
| Tianjin Haihe Hospital | Tianjin | China |
| The 8th Affiliated Hospital of Xinjiang Medical University | Ürümqi | China |
| Second People's Hospital of Weifang | Weifang | China |
| Wuhan Institute For Tuberculosis Control | Wuhan | China |
| First Affiliated Hospital of Xiamen Medical University | Xiamen | China |
| Henan Provincial Chest Hospital | Zhengzhou | China |
| Affiliated Hospital of Zunyi Medical University | Zunyi | China |
| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| 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 |
| C000590780 | contezolid |
| D064704 | Levofloxacin |
| D000077266 | Moxifloxacin |
| D002991 | Clofazimine |
| D000069349 | Linezolid |
| D003523 | Cycloserine |
| D011515 | Prothionamide |
| D011718 | Pyrazinamide |
| D010131 | Aminosalicylic Acid |
| D004977 | Ethambutol |
| 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 |
| D010619 | Phenazines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| 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 |
| D007539 | Isonicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
| D011719 | Pyrazines |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
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