The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB
NCT ID: NCT03830671
Last Updated: 2022-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
515 participants
INTERVENTIONAL
2019-03-08
2022-06-08
Brief Summary
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Detailed Description
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2. 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.
3. 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.
4. 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.
5. Sample size: 500 eligible patients will be enrolled.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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investigational arm
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.
18-month regimen containing 6 anti-TB drugs
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
Interventions
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18-month regimen containing 6 anti-TB drugs
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
Eligibility Criteria
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Inclusion Criteria
* Is aged between 18 years and 70 years.
* Has a positive sputum culture result or a positive GeneXpert result.
* Has evidence of RR-TB or MDR-TB either by GeneXpert or culture-based drug susceptibility testing (DST).
* Non pre-XDR-TB or XDR-TB.
* Is willing to use effective contraception of women at childbearing age.
* Has had a chest X-ray that is compatible with a diagnosis of pulmonary TB.
Exclusion Criteria
* Has a known allergy to any drug of the regimen.
* Is currently taking or took part in another trial less than three months before the study initiation .
* Is HIV positive.
* Has abnormal ECG with QT prolongation over 430ms of men while 450 of women.
* Is critically ill, and in the judgment of the investigator, unlikely to take part in the study.Or has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe.
* Is known to be pregnant or breast-feeding.
* Has severe cardiovascular diseases, such as heart failure, hypertension (poor blood pressure control), arrhythmia or post-infarction status.
* Has severe concomitant severe disease such as respiratory failure or cardiac insufficiency or liver and kidney injury with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 2.5 times the upper limit of normal or with serum creatinine(Cr)more than 1.3 times the upper limit of normal.
* Has Karnofsky score less than 50%
18 Years
70 Years
ALL
No
Sponsors
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Beijing Chest Hospital
OTHER
Responsible Party
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Qi Li
Director of Tuberculosis Clinical Research
Locations
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Beijing Chest Hospital
Beijing, , China
The 8th Medical Center of Chinese Pla General Hospital
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
Countries
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Other Identifiers
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2018ZX10722301-001
Identifier Type: -
Identifier Source: org_study_id
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