Multi-drug Resistant Tuberculosis Clinical Trial
Official title:
The Effect of New MDR-TB Regimen With 18 Month Duration Containing 6 Anti-tuberculosis Drugs
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.
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. ;
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 |
NCT00664313 -
TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB
|
Phase 1/Phase 2 | |
Completed |
NCT00691392 -
Linezolid Pharmacokinetics (PK) in Multi-Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) Tuberculosis (TB)
|
Phase 1/Phase 2 |