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

Beijing Chest Hospital

Status: Unknown

Conditions: Tuberculosis

Treatments: Drug: Total oral short-term therapy that includes linezolid, bedaquiline and/or cycloserine.

Study type: Interventional

Funder types: Other

Identifiers

NCT04545788

GCP-TB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

A

Active Comparator group

Description:

4-6 INH EMB PZA Pto AM Cfz Mfx / 5 EMB PZA Cfz Mfx (INH: Isoniazid, EMB: Ethambutol, PZA: Pyrazinamide, Pto: Prothionamide, AM: Amikacin, Cfz: Clofazimine, Mfx: Moxifloxacin) A group is the control group which includes injectable drugs (AM).

Treatment:

Drug: Total oral short-term therapy that includes linezolid, bedaquiline and/or cycloserine.

B

Experimental group

Description:

4-6 INH EMB PZA Pto LZD Cfz Mfx / 5 EMB PZA Cfz Mfx (INH: Isoniazid, EMB: Ethambutol, PZA: Pyrazinamide, Pto: Prothionamide, LZD: Linezolid, Cfz: Clofazimine, Mfx: Moxifloxacin) B group is the experimental groups which is total oral short-term therapy.

Treatment:

Drug: Total oral short-term therapy that includes linezolid, bedaquiline and/or cycloserine.

C

Experimental group

Description:

4-6 BDQ LZD MFX CS CFZ / 5MFX CS CFZ (BDQ: Bedaquiline, LZD: Linezolid, Mfx: Moxifloxacin, CS: Cycloserine, Cfz: Clofazimine) C group is another experimental groups which is also total oral short-term therapy, and includes new anti-TB drugs: BDQ.

Treatment:

Drug: Total oral short-term therapy that includes linezolid, bedaquiline and/or cycloserine.