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WHO has recommended that multidrug-resistant tuberculosis (MDR-TB, defined as resistance to at least isoniazid (H) and rifampicin (R) be addressed as a public health crisis and enhance capacity to deliver effective treatment and care. According to the 2018 WHO TB Report, the overall treatment success rate of MDR-TB is 55% while much lower in China at just only 41% with the 24-month regimen. In order to further verify the safety and efficiency of optimizing shorter 18-month regimen containing 6 anti-TB drugs with MDR-TB patients,500 more patients will be enrolled and observed.
Design: the study is a multi-center,open, single arm trial.
Population:patients with sputum culture positive and confirmed as MDR-TB via drug resistance of isoniazid(H),rifampicin(R),ethambutol(E)and pyrazinamide or patients with GeneXpert confirmed RR-TB.
Investigational regimen:3Am-Mfx-PZA-X-Y-Z/3Am3-Mfx-PZA-X-Y-Z/12 Mfx-PZA-X-Y-Z.X、Y、Z are the drugs susceptible or possibly susceptible to mycobacterial bacilli(The candidated drugs to be selected are:Cs-Cycloserine,Pto-Protionamide,Clr-Clarithromycin,PAS-sodium para-aminosalicylate,E-ethambutol,Bdq-Bedaquiline,Cfz-Clofazimine,Lzd-linezolid).The abbreviation of the name of the 3 drugs in the regimen is explained as follows: PZA-pyrazinamide,Am-Amikacin,Mfx-moxifloxacin)and the total duration of the regimen is 18 months.
Primary and secondary outcome measures:
The primary outcome measures include 1.the treatment success rate.2. Death rate.
The secondary outcome measures include 1.sputum conversion rate at the end of month 2, month 3,intensive phase of 6 months and treatment completion of all enrolled patients.2.Frequency of adverse drug reaction occurring during treatment.3.Radiological manifestation change of TB lesion or cavity during treatment.
Sample size: 500 eligible patients will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| investigational arm | Experimental | the arm was given investigational regimen:3Am-Mfx-PZA-X-Y-Z/3Am3-Mfx-PZA-X-Y-Z/12 Mfx-PZA-X-Y-Z.X、Y、Z are the drugs susceptible or possibly susceptible to mycobacterial bacilli(The candidated drugs to be selected are:Cs-Cycloserine,Pto-Protionamide,Clr-Clarithromycin,PAS-sodium para-aminosalicylate,E-ethambutol,Bdq-Bedaquiline,Cfz-Clofazimine,Lzd-linezolid).The abbreviation of the name of each drug in the regimen is explained as follows: PZA-pyrazinamide,Am-Amikacin,Mfx-moxifloxacin)and the total duration of the regimen is 18 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18-month regimen containing 6 anti-TB drugs | Drug | Investigational regimen:3Am-Mfx-PZA-X-Y-Z/3Am3-Mfx-PZA-X-Y-Z/12 Mfx-PZA-X-Y-Z.X、Y、Z are the drugs susceptible or possibly susceptible to mycobacterial bacilli(The candidated drugs to be selected are:Cs-Cycloserine,Pto-Protionamide,Clr-Clarithromycin,PAS-sodium para-aminosalicylate,E-ethambutol,Bdq-Bedaquiline,Cfz-Clofazimine,Lzd-linezolid).The abbreviation of the name of each drug in the regimen is explained as follows: PZA-pyrazinamide,Am-Amikacin,Mfx-moxifloxacin)and the total duration of the regimen is 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| the treatment success rate | at the end of treatment completion of all enrolled patients,an average of 18 months after the last patient enrolled | |
| death rate | at the end of treatment completion of all enrolled patients, an average of 18 months after the last patient enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| sputum conversion rate at the end of month 2, month 3,intensive phase and treatment completion. | at the end of month 2, month 3,intensive phase of 6 months since treatment initiation and treatment completion of all enrolled patients, an average of 18 months after the last enrolled patient. | |
| Frequency of adverse drug reaction occurring during treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chest Hospital | Beijing | China | ||||
| The 8th Medical Center of Chinese Pla General Hospital |
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| at the end of treatment completion of all enrolled patients, an average of 18 months after the last enrolled patient. |
| Radiological manifestation change of TB lesion or cavity at the end of month 2, month 3,intensive phase and treatment completion. | proportion of lung field the lesion accumulated taken up at different time points with the comparison to that at baseline. The number and size of cavities at different time points with comparison to that at baseline. | at the end of month 2, month 3,intensive phase of 6 months since treatment initiation and treatment completion of all enrolled patients, an average of 18 months after the last enrolled patient. |
| Beijing |
| China |
| Changchun Infectious Disease Hospital | Changchun | China |
| Hunan Institute For Tuberculosis Control | Changsha | China |
| Public Health Clinical Center of Chengdu | Chengdu | China |
| Shenzhen Third Peple's Hospital | Guangzhou | China |
| Guangzhou Chest Hospital | Guanzhou | China |
| The Affiliated Hospital of Guizhou Medical University | Guiyang | China |
| Infectious Disease Prevention Hospital in Heilongjiang Province | Harbin | China |
| Anhui Chest Hospital | Hefei | China |
| The Fourth People's Hospital of Inner Mongolia Autonomous region | Hohhot | China |
| Shandong Provincial Chest Hospital | Jinan | China |
| Shanghai Pulmonary Hospital | Shanghai | China |
| Shenyang Chest Hospital | Shenyang | China |
| Tianjin Haihe Hospital | Tianjin | China |
| Chest of Hospital of Xinjiang Uygur Autonomous Region of the PRC | Ürümqi | China |
| The Tuberculosis Prevention and Treatment Hospital of Shanxi Province | Xi'an | China |
| Xi'an Chest Hospital | Xi'an | China |
| The Fourth People's Hospital of Ningxia Autonomous Region | Yinchuan | China |
| The Infectious Disease Hospital of Wangkai Zaozhuang | Zaozhuang | China |
| 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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