Tuberculosis
Conditions
Interventions
Group 1:Chemotherapy plus GYG-017 for 2 months
Group 2:Chemotherapy plus GYG-017 for 6 months
Group 3:Chemotherapy
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years, no gender limit; 2. Body weight: 40kg- 90kg; 3. MDR/RR-PTB patients confirmed by culture drug susceptibility test or ‘’molecular drug susceptibility test’’, including pre-XDR-PTB or XDR-PTB patients; 4. Negative HIV test; 5. For women who are not breastfeeding or pregnant, consent to continue using contraception throughout the process; 6. Fully understand the purpose and requirements of the trial, and voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. HIV positive patients; 2. Sputum culture suggested that patients with non-tuberculous Mycobacteria (NTM); 3. Diabetic patients; 4. Patients allergic to alcohol (ethanol); 5. Patients with poor compliance and unable to adhere to follow-up; 6. Definite hepatobiliary diseases, including but not limited to chronic active hepatitis and/or liver insufficiency, hepatitis B large three young, AST or ALT > 3 times the upper limit of normal, TBIL > 2 times the upper limit of normal; 7. History of any of the following kidney diseases or kidney disease-related manifestations: history of unstable or rapidly progressive kidney disease; Moderate/severe renal impairment or end-stage renal disease (eGFR = 133umol/L; Female Cr >= 124umol/L).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Negative conversion rate of sputum bacteria; | — |
Countries
China
Contacts
Public ContactSha Wei
Outcome results
None listed