Randomized Controlled Multi-center Short Course Treatment for Rifampicin Resistant Tuberculosis

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is a randomized, controlled, multi-center clinical study. The main purpose of this study was to study the efficacy and safety data of total oral short-term therapy as an alternative to injection in the treatment of newly diagnosed RR-TB patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Chest Hospital
• Treatments: Bedaquiline; Cycloserine; Linezolid

Criteria

Inclusion Criteria:

• signed informed consent and accepted follow-up;

• the age is between 18 and 65 years old, both male and female, including inpatients and outpatients;

• no use of anti tuberculosis drugs, or use of anti tuberculosis drugs less than 1 month;

• the results of molecular biology test confirmed rifampicin resistance or MDR-TB patients;

• chest CT examination confirmed pulmonary tuberculosis, pulmonary lesions, or cavity;

• premenopausal women had negative pregnancy urine test and agreed to use high-efficiency contraceptive measures during the study period.

Exclusion Criteria:

• drug sensitivity test or molecular drug sensitivity results show that the drug resistance (except isoniazid) or any component of the drug has a history of allergy, or is taking any drug that is contraindicated to the drug in the short-term treatment program;

• severe renal insufficiency (creatinine clearance rate (CrCl) less than 30 ml / min).

• liver function impairment (ALT and / or AST level 3 times higher than the upper limit of laboratory reference value, if it is temporary increase, it can be included after treatment recovery);

• those who are unable to participate in or comply with the treatment and follow-up;

• Q-T interval > 450 millisecond;

• have a history of cardiovascular diseases or are suffering from such diseases as heart failure, hypertension (poor blood pressure control), arrhythmia or post myocardial infarction state;

• pregnant or lactating women;

• those who are unable to take oral drugs;

• those who are currently participating in other clinical trials;

• patients with HIV positive or active viral hepatitis.