Tuberculosis
Conditions
Interventions
Bedaquiline group:None
Control group:None
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Patients with newly diagnosed MDR/RR-TB (culture or molecular testing is confirmed); (2) Age 18-65 years old; (3) Body mass index (BMI) 15.0 -28.0 kg/m^2; (4) the use of individualized long-course multidrug-resistant regimens.
Exclusion criteria
Exclusion criteria: (1) Received treatment for multidrug-resistant tuberculosis (treatment history in index medical history, whether there is a history of second-line drug use in previous drug history); (2) HIV-positive; (3) Manifestations of severe extrapulmonary tuberculosis or neurological tuberculosis; (4) Severe arrhythmias requiring medication; QT interval corrected using Fridericia's formula (QTcF) exceeds 450 msec; risk factors for torsade de pointes; (5) Concomitant serious illness, alcohol or drug abuse, pregnancy or breastfeeding; (6) Previous bedaquiline therapy; (7) The drug susceptibility results before medication showed that an effective background treatment regimen could not be formed (Therapeutic effective drugs <4 pcs).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sputum culture convertion time;Treatment Success Rate; | — |
Countries
China
Contacts
Public ContactLan Yao
Shanghai Pulmonary Hospital
Outcome results
None listed