Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)

Summary

The INSPIRE-TB study is a pragmatic, multicentre, randomised, controlled, non-inferiority open-label trial to evaluate the efficacy and safety of seven 9-month oral regimens compared to a 9-month standard of care (SOC) regimen in RR-TB participants susceptible to fluoroquinolones, and a bedaquiline-containing 9-month oral regimen compared to a 20-month conventional regimen in RR-TB participants resistant to fluoroquinolones

Conditions

• Multidrug Resistant Tuberculosis
• Rifampicin Resistant Tuberculosis
• Pre-XDR-TB

Interventions

COMBINATION_PRODUCT

Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z

A-SOC: 4Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z/5Lfx(Mfx)+Cfz(Cs)+E+Z During the intensive phase: Bedaquiline(Linezolid);Levofloxacin(Moxifloxacin) All treatment is taken orally

COMBINATION_PRODUCT

A1

9Bdq(6m)+Fq+Lzd+Cs+Cfz

COMBINATION_PRODUCT

A2a

9Bdq(6m)+Fq+Lzd(600mg)+Cs+Z

COMBINATION_PRODUCT

A2b

9Bdq(6m)+Fq+Lzd(2m)+Cs+Z

COMBINATION_PRODUCT

A2c

9Bdq(6m)+Fq+Lzd(600mg-300mg)+Cs+Z

COMBINATION_PRODUCT

A3

9Bdq(6m)+Fq+Lzd+Cfz+Z

COMBINATION_PRODUCT

A4

9Bdq(6m)+Fq+Cfz+Cs+Z

COMBINATION_PRODUCT

A5

9Fq+Lzd+Cfz+Cs+Z

COMBINATION_PRODUCT

B-SOC

6Bdq+Lzd+Cs+Cfz/14Lzd+Cfz+Cs

COMBINATION_PRODUCT

B1

9Bdq(6m)+Lzd+Cs+Cfz+Z

Sponsors & Collaborators

• Huashan Hospital

  lead OTHER

Principal Investigators

• Wenhong Zhang, PHD · Huashan Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-23

Primary Completion

2026-12-01

Completion

2027-12-01

Countries

• China

Study Locations