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

RecruitingPhase 3Ages 16 Years - 75 YearsAllHuashan Hospital
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Male or female patients aged 16-75 years with weight over 30kg, regardless of HIV status; 2. 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) ; 3. Signed informed consent form (ICF). Exclusion Criteria: 1. Known allergies, hypersensitivity, or contraindication to any of the study drugs as described in additional material; 2. Participants combined with central nervous system TB, tuberculous osteomyelitis or arthritis, hematogenous disseminated pulmonary TB; 3. Patients known to be pregnant or breastfeeding at the time of enrollment; 4. Patients who have received second-line MDR-TB treatment for 14 days or more prior to enrollment; 5. Patients in critical condition and expected survival is estimated by physician to be less than 12 weeks.
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What it tests

  • Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z
  • A1
  • A2a
  • A2b
  • A2c
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Where

5 sites
Guiyang Public Health Treatment Center
Guiyang, China
People's Hospital of Qiandongnan
Kaili, China
The Third People's Hospital of Liupanshui
Liupanshui, China
Affiliated Hospital of Zunyi Medical University
Zunyi, China
Huashan Hospital of Fudan University
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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