A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis

Summary

Rifampicin-resistant tuberculosis (RR-TB) is characterized by a long treatment course, high incidence of adverse reactions, low cure rate and high recurrence rate. This is related to the large number of drugs in the RR-TB treatment regimen, high incidence of adverse reactions and long treatment course, which leads to poor patient compliance. There is an urgent need for new, effective and safe short-course regimens for drug-resistant tuberculosis. A 6-month short-course oral regimen containing pretomanid was introduced in 2020. However, as pretomanid is not yet available in China, it has not been verified and promoted in China. Pretomanid is expected to be launched in China in 2025, and it is urgent to evaluate the application of the new short-course regimen containing pretomanid in the Chinese population. This study is a prospective, randomized, controlled clinical trial. It plans to include RR-TB patients aged ≥12 years in multiple domestic centers. Under the guidance of rapid molecular drug susceptibility test results, the experimental group will be treated with bedaquiline, pretomanid, linezolid and moxifloxacin for 6 months, while the control group will be treated with bedaquiline, delamanid, linezolid and levofloxacin or bedaquiline, delamanid, linezolid and clofazimine for 6 months, depending on the susceptibility to fluoroquinolones. For patients with unknown susceptibility to fluoroquinolones, bedaquiline, delamanid, linezolid, levofloxacin and clofazimine will be used for 6 months. The efficacy and safety will be evaluated to provide a basis for the introduction and implementation of new short-course regimens for RR-TB in China.

Conditions

• Efficacy and Safety

Interventions

DRUG

bedaquiline

Administer 400 mg orally once daily for the first two weeks, followed by 200 mg orally three times a week for the subsequent 22 weeks.

DRUG

Pretomanid (Pa)

Administer 200 mg orally once daily for six months.

DRUG

linezolid

Administer 600 mg orally once daily for six months.

DRUG

Moxifloxacin (M)

Administer 400 mg orally once daily for six months.

DRUG

Delamanid (D)

Administer 100 mg orally twice daily for six months.

DRUG

Levofloxacin

Administer 800 mg orally once daily for six months.

DRUG

clofazimine

Administer 100 mg orally once daily for six months.

Sponsors & Collaborators

• Wuhan Pulmonary Hospital

  lead OTHER

Principal Investigators

• Shuang Wei, M.D. · Wuhan Pulmonary Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2027-09-30

Completion

2028-09-30