Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort

Summary

The goal of this clinical trial is to compare the efficacy and safety of a Contezolid and Delamanid-Containing short regimen to standard longer regimen in Rifampicin-resistant pulmonary tuberculosis (RR-TB). The main questions it aims to answer are:

* Is the efficacy of short regimen non-inferior to standard regimen?
* Is the short regimen safe enough to replace the standard regimen?

Participants will:

* Be given with either short or standard regimen for RR-TB treatment
* Be asked to complete the scheduled visit as planned.

Conditions

• Pulmonary Tuberculosis
• Rifampicin-resistant Tuberculosis

Interventions

DRUG

Bedaquiline

Oral, 400mg qd for 2 weeks, then 200 mg 3 times per week

DRUG

Delamanid

Oral, 100mg bid

DRUG

Contezolid

Oral, 800mg bid

DRUG

Levofloxacin

Oral, 400mg qd for weight \<50kg, 600-750mg qd for weight ≥50kg

DRUG

Moxifloxacin

Oral, 400mg qd

DRUG

Clofazimine

Oral, 100mg qd

DRUG

Linezolid

Oral, 600mg qd

DRUG

Cycloserine

Oral, 250mg bid

DRUG

Prothionamide

Oral, 600mg qd for weight \<50kg, 600-800mg qd for weight ≥50kg

DRUG

Pyrazinamide

Oral, 1500mg qd for weight \<50kg, 1750mg qd for weight ≥50kg

DRUG

Para-Aminosalicylic Acid

8000mg qd for weight \<50kg, 10000mg qd for weight ≥50kg

DRUG

Ethambutol

750mg qd for weight \<50kg, 1000mg qd for weight ≥50kg

Sponsors & Collaborators

• National Medical Center for Infectious Diseases

  collaborator UNKNOWN

• Beijing Chest Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-22

Primary Completion

2026-10-01

Completion

2026-12-31

Countries

• China

Study Locations