Tuberculosis
Conditions
Keywords
Tuberculosis, rifampin resistant, oral, shorter.
Brief 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.
Detailed description
A group: 4-6 INH EMB PZA Pto AM Cfz Mfx / 5 EMB PZA Cfz Mfx B group: 4-6 INH EMB PZA Pto LZD Cfz Mfx / 5 EMB PZA Cfz Mfx C group: 4-6 BDQ LZD MFX CS CFZ / 5MFX CS CFZ (INH: Isoniazid, EMB: Ethambutol, PZA: Pyrazinamide, Pto: Prothionamide, AM: Amikacin, Cfz: Clofazimine, Mfx: Moxifloxacin, LZD: Linezolid, BDQ: Bedaquiline, CS: Cycloserine) A group is the control group which includes injectable drugs (AM). B group and C group are the experimental groups which are total oral short-term therapy.
Interventions
DRUGTotal oral short-term therapy that includes linezolid, bedaquiline and/or cycloserine.
AM is the traditional anti-TB drugs. Linezolid, bedaquiline and/or cycloserine, that might have potential efficacy of replacing injectable anti-TB drugs, are included into the total oral short-term therapy, and replace AM.
Sponsors
Beijing Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Culture of Mycobacterium tuberculosis in sputum. | Through study completion, an average of 1 year. | Mycobacterium tuberculosis culture of sputum will be carried out every month to understand the negative conversion rate and time of sputum bacteria, and then to understand the cure rate of patients. The final aim is to understand the efficacy of the total oral short-term anti-tuberculosis regimen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effect. | Through study completion, an average of 1 year. | All the types and frequency of adverse reactions that related to anti-tuberculosis drug were collected. |
Countries
China
Contacts
Primary ContactWENJUAN NIE, Director
Backup ContactJING LIU, Doctor
Outcome results
None listed