Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)

Launched by HUASHAN HOSPITAL · Oct 5, 2021

Keywords

ClinConnect Summary

The INSPIRE-TB trial is studying a new treatment approach for patients with multidrug-resistant tuberculosis (TB) that is resistant to a medication called rifampicin. The goal of this trial is to see if a shorter, all-oral treatment plan—using 4 to 5 specific anti-TB drugs—can be effective and safe for patients. This treatment is guided by a quick test that checks which drugs will work best for each patient. The study is taking place in provinces of China where rifampicin-resistant TB is common, and it hopes to create a new treatment pathway that could be adopted across the country.

To participate in this trial, patients must be willing to sign an agreement and have confirmed rifampicin-resistant TB through a specific test. Unfortunately, those on different treatment regimens or with certain types of TB outside the lungs won't qualify. If eligible, participants can expect to receive individualized care based on their test results, with the possibility of completing treatment in 9 to 12 months. This trial aims not only to improve treatment for patients but also to update national guidelines for managing this challenging form of TB.

Gender

ALL

Eligibility 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.