Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03830671
Other study ID # 2018ZX10722301-001
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 8, 2019
Est. completion date June 8, 2022

Study information

Verified date October 2022
Source Beijing Chest Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 515
Est. completion date June 8, 2022
Est. primary completion date June 8, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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%

Study Design


Related Conditions & MeSH terms

  • Multi-drug Resistant Tuberculosis
  • Tuberculosis
  • Tuberculosis, Multidrug-Resistant

Intervention

Drug:
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

Locations

Country Name City State
China 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

Sponsors (1)

Lead Sponsor Collaborator
Beijing Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the treatment success rate at the end of treatment completion of all enrolled patients,an average of 18 months after the last patient enrolled
Primary death rate at the end of treatment completion of all enrolled patients, an average of 18 months after the last patient enrolled
Secondary 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.
Secondary 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.
Secondary 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.
See also
  Status Clinical Trial Phase
Recruiting NCT03057756 - Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance
Completed NCT04207112 - Economic Evaluation of New MDR TB Regimens Phase 2/Phase 3
Completed NCT03000517 - PK of Levofloxacin in MDR-TB Patients N/A
Completed NCT03470233 - Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB
Withdrawn NCT01600963 - A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis Phase 3
Recruiting NCT03575299 - Clinical Study on Adoptive Treatment of MDR-TB With Allogeneic γδT Cells Phase 1
Recruiting NCT03827811 - Pharmacometrics to Advance Novel Regimens for Drug-resistant Tuberculosis-PandrTB Tuberculosis
Completed NCT04342598 - Case Control Study of Vitamin D Status and Adult Multidrug-resistant Pulmonary Tuberculosis in Maharashtra, India
Completed NCT04309656 - A Study in Two Panels of Healthy Adult Participants to Assess Single-Dose Immediate-Release and Single-Dose Dispersible Formulations of Pretomanid Phase 1
Completed NCT03822156 - Clinical Analysis of the Patients With Cavitary Pulmonary TB and Endobronchial TB in the PPM-UUH Cohort
Completed NCT00425113 - Metronidazole for Pulmonary Tuberculosis (South Korea) Phase 2
Active, not recruiting NCT04081077 - PRACTECAL-PKPD Sub Study Phase 2/Phase 3
Recruiting NCT04397536 - New Genomic Techniques and Management of Multidrug-resistant Tuberculosis
Completed NCT00691392 - Linezolid Pharmacokinetics (PK) in Multi-Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) Tuberculosis (TB) Phase 1/Phase 2
Completed NCT00664313 - TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB Phase 1/Phase 2