NCT05081401RecruitingPhase 3
Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
Source: ClinicalTrials.gov · Last updated 6 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1050 (estimated)
- First submitted
- 5 Oct 2021
- Start date
- 23 May 2022
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Huashan Hospital
- Diseases
- Tuberculosis
- NCT number
- NCT05081401
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1050
- From 23 May 2022 to the primary completion date, 1 Dec 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received second-line MDR-TB treatment for 14 days or more prior to enrollment;
Other illness
- 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.
Other
- 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;
Who the study is looking for
- 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).
Age in the registry: 16 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guiyang Public Health Treatment Center Coordinator of this site? Confirm its status | Guiyang | China | Recruiting |
| People's Hospital of Qiandongnan Coordinator of this site? Confirm its status | Kaili | China | Recruiting |
| The Third People's Hospital of Liupanshui Coordinator of this site? Confirm its status | Liupanshui | China | Recruiting |
| Huashan Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Affiliated Hospital of Zunyi Medical University Coordinator of this site? Confirm its status | Zunyi | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.