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
Male or female patients aged 16-75 years with weight over 30kg, regardless of HIV status;
Pulmonary TB with rifampicin resistance diagnosed with either WHO-approved rapid molecular diagnostic test or phenotype drug susceptibility test (within 60 days prior to randomisation) ;
Signed informed consent form (ICF).
Known allergies, hypersensitivity, or contraindication to any of the study drugs as described in additional material;
Participants combined with central nervous system TB, tuberculous osteomyelitis or arthritis, hematogenous disseminated pulmonary TB;
Patients known to be pregnant or breastfeeding at the time of enrollment;
Patients who have received second-line MDR-TB treatment for 14 days or more prior to enrollment;
Parallel
Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z
Combination productA-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
Combination product9Bdq(6m)+Fq+Lzd+Cs+Cfz
A2a
Combination product9Bdq(6m)+Fq+Lzd(600mg)+Cs+Z
A2b
Combination product9Bdq(6m)+Fq+Lzd(2m)+Cs+Z
A2c
Combination product9Bdq(6m)+Fq+Lzd(600mg-300mg)+Cs+Z
A3
Combination product9Bdq(6m)+Fq+Lzd+Cfz+Z
A4
Combination product9Bdq(6m)+Fq+Cfz+Cs+Z
A5
Combination product9Fq+Lzd+Cfz+Cs+Z
B-SOC
Combination product6Bdq+Lzd+Cs+Cfz/14Lzd+Cfz+Cs
B1
Combination product9Bdq(6m)+Lzd+Cs+Cfz+Z
10
Treatment groupsSee each treatment group below.
a favorable outcome at the end of study
A favorable outcome is defined by the absence of previous unfavorable, and the last two culture results are negative. These two cultures must be taken from respiratory samples collected on separate visits at least 7 days apart. The latest culture sample should be collected between month 21 and 23.
The median time to sputum culture conversion
Time from treatment initiation to the first of two consecutive negative sputum culture conversion without an intervening positive culture.
The proportion of participants with grade 3 or higher AEs, SAEs
To compare the proportion of patients who experience grade 3 or greater adverse events (AE graded according to the Common terminology criteria for adverse events, version 5.0), during treatment or follow-up in safety population.
All-cause mortality and treatment relevant mortality
To compare the death rate and treatment relevant death rate during treatment or follow-up in safety population.
The proportion of participants with treatment relevant SAEs
To compare the proportion of patients treatment relevant SAEs, during treatment or follow-up in safety population.
Click on the lead sponsor to view all of their trials.
