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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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)

Who May Qualify: 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 willing to sign a consent form form (ICF). Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

COMBINATION_PRODUCT

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

COMBINATION_PRODUCT

A1

9Bdq(6m)+Fq+Lzd+Cs+Cfz

COMBINATION_PRODUCT

A2a

9Bdq(6m)+Fq+Lzd(600mg)+Cs+Z

COMBINATION_PRODUCT

A2b

9Bdq(6m)+Fq+Lzd(2m)+Cs+Z

COMBINATION_PRODUCT

A2c

9Bdq(6m)+Fq+Lzd(600mg-300mg)+Cs+Z

COMBINATION_PRODUCT

A3

9Bdq(6m)+Fq+Lzd+Cfz+Z

COMBINATION_PRODUCT

A4

9Bdq(6m)+Fq+Cfz+Cs+Z

COMBINATION_PRODUCT

A5

9Fq+Lzd+Cfz+Cs+Z

COMBINATION_PRODUCT

B-SOC

6Bdq+Lzd+Cs+Cfz/14Lzd+Cfz+Cs

COMBINATION_PRODUCT

B1

9Bdq(6m)+Lzd+Cs+Cfz+Z

Locations (5)

Guiyang Public Health Treatment Center
Guiyang, Guizhou, China
People's Hospital of Qiandongnan
Kaili, Guizhou, China
The Third People's Hospital of Liupanshui
Liupanshui, Guizhou, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China