Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
About This Trial
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
Who May Be Eligible (Plain English)
Original Eligibility Criteria
View original clinical language
Treatments Being Tested
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
A1
9Bdq(6m)+Fq+Lzd+Cs+Cfz
A2a
9Bdq(6m)+Fq+Lzd(600mg)+Cs+Z
A2b
9Bdq(6m)+Fq+Lzd(2m)+Cs+Z
A2c
9Bdq(6m)+Fq+Lzd(600mg-300mg)+Cs+Z
A3
9Bdq(6m)+Fq+Lzd+Cfz+Z
A4
9Bdq(6m)+Fq+Cfz+Cs+Z
A5
9Fq+Lzd+Cfz+Cs+Z
B-SOC
6Bdq+Lzd+Cs+Cfz/14Lzd+Cfz+Cs
B1
9Bdq(6m)+Lzd+Cs+Cfz+Z