Overview

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.