New all-oral treatment for rifampicin-resistant tuberculosis
Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
This study is testing seven new all-oral treatment options for people with rifampicin-resistant tuberculosis to see if they work better than the standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1050 (estimated) |
| Ages | 16 Years to 75 Years |
| Sex | All |
| Sponsor | Huashan Hospital Academic / other |
| Locations | 5 sites (Guiyang, Guizhou and 4 other locations) |
| Trial ID | NCT05081401 on ClinicalTrials.gov |
What this trial studies
The INSPIRE-TB study evaluates the efficacy and safety of seven different 9-month oral treatment regimens for patients with rifampicin-resistant tuberculosis (RR-TB) who are susceptible to fluoroquinolones. This pragmatic, multicenter, randomized, controlled trial compares these experimental regimens to a standard of care regimen. The study also includes a specific regimen for patients with pre-XDR TB. Participants will undergo molecular drug susceptibility testing to tailor their treatment and minimize toxicity.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 16-75 with pulmonary TB and rifampicin resistance, regardless of HIV status.
Not a fit: Patients with known allergies to study drugs, central nervous system TB, or those in critical condition are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a shorter, more effective treatment option for patients with rifampicin-resistant tuberculosis.
How similar studies have performed: Other studies have shown promise with shorter treatment regimens for tuberculosis, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guiyang, Guizhou and 4 other locations
- Guiyang Public Health Treatment Center — Guiyang, Guizhou, China (Recruiting)
- People's Hospital of Qiandongnan — Kaili, Guizhou, China (Recruiting)
- The Third People's Hospital of Liupanshui — Liupanshui, Guizhou, China (Recruiting)
- Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (Recruiting)
- Huashan Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Wenhong Zhang, PHD — Huashan Hospital
- Study coordinator: Feng Sun, Dr.
- Email: feng.sun@nmcid.org.cn
- Phone: (086)15921403893
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.