Clinical Research Directory
Browse clinical research sites, groups, and studies.
Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
Sponsor: Huashan Hospital
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
Key Details
Gender
All
Age Range
16 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
1050
Start Date
2022-05-23
Completion Date
2027-12-01
Last Updated
2025-04-06
Healthy Volunteers
No
Interventions
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
A1
9Bdq(6m)+Fq+Lzd+Cs+Cfz
A2a
9Bdq(6m)+Fq+Lzd(600mg)+Cs+Z
A2b
9Bdq(6m)+Fq+Lzd(2m)+Cs+Z
A2c
9Bdq(6m)+Fq+Lzd(600mg-300mg)+Cs+Z
A3
9Bdq(6m)+Fq+Lzd+Cfz+Z
A4
9Bdq(6m)+Fq+Cfz+Cs+Z
A5
9Fq+Lzd+Cfz+Cs+Z
B-SOC
6Bdq+Lzd+Cs+Cfz/14Lzd+Cfz+Cs
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