Tests shorter all-oral treatments for drug-resistant tuberculosis
Compares shorter oral tuberculosis drug regimens with standard treatment in people with rifampicin-resistant tuberculosis.
Plain-language title generated from the registry record
Registry title: Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
Key facts
- Where
- Guiyang, Kaili, Liupanshui, Shanghai, and Zunyi, ChinaSee the 5 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 75 years old?
Source: NCT05081401, who can take part
Where in China
- Guiyang Public Health Treatment CenterGuiyang, ChinaTaking people
- People's Hospital of QiandongnanKaili, ChinaTaking people
- The Third People's Hospital of LiupanshuiLiupanshui, ChinaTaking people
- Huashan Hospital of Fudan UniversityShanghai, ChinaTaking people
- Affiliated Hospital of Zunyi Medical UniversityZunyi, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Huashan Hospital
- Trial code
- NCT05081401
- Record updated
- 6 April 2025
- Original description
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 fluoroquinolonesRead full original descriptionShow less
Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
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
Inclusion: 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: Patients who have received second-line MDR-TB treatment for 14 days or more prior to enrollment; Known allergies, hypersensitivity, or contraindication to any of the study drugs as described in additional material; Patients in critical condition and expected survival is estimated by physician to be less than 12 weeks; 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.