NCT05081401View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,050

Participants

Timeline

Start Date

May 23, 2022

Primary Completion Date

December 1, 2026

Study Completion Date

December 1, 2027

Conditions
Multidrug Resistant TuberculosisRifampicin Resistant TuberculosisPre-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

Trial Locations (5)

200040

RECRUITING

Huashan Hospital of Fudan University, Shanghai

Unknown

RECRUITING

Guiyang Public Health Treatment Center, Guiyang

RECRUITING

People's Hospital of Qiandongnan, Kaili

RECRUITING

The Third People's Hospital of Liupanshui, Liupanshui

RECRUITING

Affiliated Hospital of Zunyi Medical University, Zunyi

All Listed Sponsors
lead

Huashan Hospital

OTHER