The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB
The Effect of New MDR-TB Regimen With 18 Month Duration Containing 6 Anti-tuberculosis Drugs
1 other identifier
interventional
515
1 country
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2019
Typical duration for phase_4
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2019
CompletedFirst Posted
Study publicly available on registry
February 5, 2019
CompletedStudy Start
First participant enrolled
March 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 8, 2022
CompletedOctober 12, 2022
October 1, 2022
3.3 years
January 31, 2019
October 10, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
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.
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.
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.
Study Arms (1)
investigational arm
EXPERIMENTALthe 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.
Interventions
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
You may qualify if:
- Is willing and able to give informed consent to participate in the trial treatment and follow-up.
- 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.
You may not qualify if:
- pre-XDR-TB or XDR-TB.
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Tuberculosis Clinical Research
Study Record Dates
First Submitted
January 31, 2019
First Posted
February 5, 2019
Study Start
March 8, 2019
Primary Completion
June 8, 2022
Study Completion
June 8, 2022
Last Updated
October 12, 2022
Record last verified: 2022-10