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RECRUITING
NCT05081401
PHASE3

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

Sponsor: Huashan Hospital

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

16 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1050

Start Date

2022-05-23

Completion Date

2027-12-01

Last Updated

2025-04-06

Healthy Volunteers

No

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

Locations (5)

Guiyang Public Health Treatment Center

Guiyang, Guizhou, China

People's Hospital of Qiandongnan

Kaili, Guizhou, China

The Third People's Hospital of Liupanshui

Liupanshui, Guizhou, China

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, China