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;
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Treatment groupsSee each treatment group below.
Huashan Hospital
Lead sponsor