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CompletedNCT03830671Updated Oct 12, 2022

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

A Phase 4 interventional study of 18-month regimen containing 6 anti-TB drugs in Multi-drug Resistant Tuberculosis, sponsored by Beijing Chest Hospital. Completed at 20 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-10-12.

Sponsored by Beijing Chest Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
515
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description
  1. Design: the study is a multi-center,open, single arm trial.
  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.
02

Conditions studied

  • Multi-drug Resistant Tuberculosis
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 515 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Beijing Chest Hospital is the lead sponsor of 31 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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%
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
515 participants (actual)

Study arms

  • Experimental
    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.

    Drug: 18-month regimen containing 6 anti-TB drugs

Interventions

  • Drug18-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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

    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.

07

Study locations

20 sites
  • 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
  • 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
  • Chest of Hospital of Xinjiang Uygur Autonomous Region of the PRC
    Ürümqi, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03830671
Lead sponsor
Beijing Chest Hospital
Responsible party
Qi Li (Director of Tuberculosis Clinical Research, Beijing Chest Hospital) — Principal investigator
First posted
Feb 5, 2019
Start date
Mar 8, 2019
Primary completion
Jun 8, 2022
Completion
Jun 8, 2022
Last update
Oct 12, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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