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

  • STATUS
    Recruiting
  • days left to enroll
    87
  • participants needed
    200
  • sponsor
    Beijing Chest Hospital
Updated on 25 January 2021

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.

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.

Details
Condition Tuberculosis, tb (tuberculosis)
Treatment Total oral short-term therapy that includes linezolid, bedaquiline and/or cycloserine.
Clinical Study IdentifierNCT04545788
SponsorBeijing Chest Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
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