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The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB

Primary Purpose

Multi-drug Resistant Tuberculosis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
18-month regimen containing 6 anti-TB drugs
Sponsored by
Beijing Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multi-drug Resistant Tuberculosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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%

Sites / Locations

  • Beijing Chest Hospital
  • The 8th Medical Center of Chinese Pla General Hospital
  • Changchun Infectious Disease Hospital
  • Hunan Institute For Tuberculosis Control
  • Public Health Clinical Center of Chengdu
  • Shenzhen Third Peple's Hospital
  • Guangzhou Chest Hospital
  • The Affiliated Hospital of Guizhou Medical University
  • Infectious Disease Prevention Hospital in Heilongjiang Province
  • Anhui Chest Hospital
  • The Fourth People's Hospital of Inner Mongolia Autonomous region
  • Shandong Provincial Chest Hospital
  • Shanghai Pulmonary Hospital
  • Shenyang Chest Hospital
  • Tianjin Haihe Hospital
  • The Tuberculosis Prevention and Treatment Hospital of Shanxi Province
  • Xi'an Chest Hospital
  • The Fourth People's Hospital of Ningxia Autonomous Region
  • The Infectious Disease Hospital of Wangkai Zaozhuang
  • Chest of Hospital of Xinjiang Uygur Autonomous Region of the PRC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

investigational arm

Arm Description

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.

Outcomes

Primary Outcome Measures

the treatment success rate
death rate

Secondary Outcome Measures

sputum conversion rate at the end of month 2, month 3,intensive phase and treatment completion.
Frequency of adverse drug reaction occurring during treatment.
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.

Full Information

First Posted
January 31, 2019
Last Updated
October 10, 2022
Sponsor
Beijing Chest Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03830671
Brief Title
The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB
Official Title
The Effect of New MDR-TB Regimen With 18 Month Duration Containing 6 Anti-tuberculosis Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 8, 2019 (Actual)
Primary Completion Date
June 8, 2022 (Actual)
Study Completion Date
June 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chest Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multi-drug Resistant Tuberculosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
515 (Actual)

8. Arms, Groups, and Interventions

Arm Title
investigational arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
18-month regimen containing 6 anti-TB drugs
Intervention Description
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
Primary Outcome Measure Information:
Title
the treatment success rate
Time Frame
at the end of treatment completion of all enrolled patients,an average of 18 months after the last patient enrolled
Title
death rate
Time Frame
at the end of treatment completion of all enrolled patients, an average of 18 months after the last patient enrolled
Secondary Outcome Measure Information:
Title
sputum conversion rate at the end of month 2, month 3,intensive phase and treatment completion.
Time Frame
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.
Title
Frequency of adverse drug reaction occurring during treatment.
Time Frame
at the end of treatment completion of all enrolled patients, an average of 18 months after the last enrolled patient.
Title
Radiological manifestation change of TB lesion or cavity at the end of month 2, month 3,intensive phase and treatment completion.
Description
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.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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%
Facility Information:
Facility Name
Beijing Chest Hospital
City
Beijing
Country
China
Facility Name
The 8th Medical Center of Chinese Pla General Hospital
City
Beijing
Country
China
Facility Name
Changchun Infectious Disease Hospital
City
Changchun
Country
China
Facility Name
Hunan Institute For Tuberculosis Control
City
Changsha
Country
China
Facility Name
Public Health Clinical Center of Chengdu
City
Chengdu
Country
China
Facility Name
Shenzhen Third Peple's Hospital
City
Guangzhou
Country
China
Facility Name
Guangzhou Chest Hospital
City
Guanzhou
Country
China
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang
Country
China
Facility Name
Infectious Disease Prevention Hospital in Heilongjiang Province
City
Harbin
Country
China
Facility Name
Anhui Chest Hospital
City
Hefei
Country
China
Facility Name
The Fourth People's Hospital of Inner Mongolia Autonomous region
City
Hohhot
Country
China
Facility Name
Shandong Provincial Chest Hospital
City
Jinan
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
Country
China
Facility Name
Shenyang Chest Hospital
City
Shenyang
Country
China
Facility Name
Tianjin Haihe Hospital
City
Tianjin
Country
China
Facility Name
The Tuberculosis Prevention and Treatment Hospital of Shanxi Province
City
Xi'an
Country
China
Facility Name
Xi'an Chest Hospital
City
Xi'an
Country
China
Facility Name
The Fourth People's Hospital of Ningxia Autonomous Region
City
Yinchuan
Country
China
Facility Name
The Infectious Disease Hospital of Wangkai Zaozhuang
City
Zaozhuang
Country
China
Facility Name
Chest of Hospital of Xinjiang Uygur Autonomous Region of the PRC
City
Ürümqi
Country
China

12. IPD Sharing Statement

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The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB

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