Multidrug resistant/rifampin-resistant tuberculosis, MDR/RR-TB
Conditions
Interventions
Experimental group:Treatment includes bedaquiline, delamanid, linezolid, clofazimine, levofloxacin, once daily for 6 months. If the smear does not turn negative at the end of 4 months of treatment, it
clofazimine, 100 mg
Delamani, 100 mg bid
levofloxacin: 30 kg50kg,800 mg
Linezolid, 600 mg.
Sponsors
Wuhan Jinyintan Hospital (Wuhan Infectious Disease Hospital)
Eligibility
Sex/Gender
All
Age
14 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Be willing to be treated with a short-course MDR-TB regimen and sign an informed consent form (illiterate patients gave assent in the presence of a witness); 2. Aged 14 years or above; 3. The respiratory tract specimens were resistant to rifampicin by Xpert, dissolution curve or traditional drug susceptibility test; 4. No previous treatment with second-line anti-TB drugs, or treatment for up to 1 month; 5. Permanent residents of the pilot areas who have no plan to work outside the country during the treatment period; 6. The female patient did not plan to become pregnant during the treatment; 7. Be willing to follow the follow-up schedule and pilot project process.
Exclusion criteria
Exclusion criteria: 1. Known to be pregnant or breastfeeding; 2. Inability to take oral medications; 3. AST or ALT > 3 times the upper limit of normal; 4. Contraindications to any drug in the short-course treatment of MDR-TB; 5. Known allergy to any fluoroquinolone antibiotic; 6.QTcF > 450 ms; 7. Currently participating in another clinical trial of a medical product; 8. Presence of any social or medical condition identified by the researcher as potentially unsafe to participate in the pilot program.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful treatment rate (including cure and completion of treatment);Treatment failure rate;Loss to follow-up rate;Mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tuberculosis recurrence rate after successful treatment; | — |
Countries
China
Contacts
Public ContactNie Qi
Wuhan Jinyintan Hospital (Wuhan Infectious Disease Hospital)
Outcome results
None listed