Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
Huashan Hospital
1,050 participants
May 23, 2022
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria3
- 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).
Exclusion Criteria5
- 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;
- Patients in critical condition and expected survival is estimated by physician to be less than 12 weeks.
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Interventions
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
9Bdq(6m)+Fq+Lzd+Cs+Cfz
9Bdq(6m)+Fq+Lzd(600mg)+Cs+Z
9Bdq(6m)+Fq+Lzd(2m)+Cs+Z
9Bdq(6m)+Fq+Lzd(600mg-300mg)+Cs+Z
9Bdq(6m)+Fq+Lzd+Cfz+Z
9Bdq(6m)+Fq+Cfz+Cs+Z
9Fq+Lzd+Cfz+Cs+Z
6Bdq+Lzd+Cs+Cfz/14Lzd+Cfz+Cs
9Bdq(6m)+Lzd+Cs+Cfz+Z
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT05081401