Actively Recruiting
Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
Led by Huashan Hospital · Updated on 2025-04-06
1050
Participants Needed
5
Research Sites
288 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 16-75 years weighing over 30kg
- Diagnosed pulmonary tuberculosis with rifampicin resistance confirmed by WHO-approved tests within 60 days prior to randomization
- Signed informed consent form
You will not qualify if you...
- Known allergies or contraindications to study drugs
- Central nervous system tuberculosis, tuberculous osteomyelitis or arthritis, or hematogenous disseminated pulmonary tuberculosis
- Pregnant or breastfeeding at enrollment
- Received second-line MDR-TB treatment for 14 days or more before enrollment
- Critical condition with expected survival less than 12 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Guiyang Public Health Treatment Center
Guiyang, Guizhou, China
Actively Recruiting
2
People's Hospital of Qiandongnan
Kaili, Guizhou, China
Actively Recruiting
3
The Third People's Hospital of Liupanshui
Liupanshui, Guizhou, China
Actively Recruiting
4
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Actively Recruiting
5
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
F
Feng Sun, Dr.
CONTACT
Y
Yang Li, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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