NCT05081401 Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
| NCT ID | NCT05081401 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Huashan Hospital |
| Condition | Multidrug Resistant Tuberculosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,050 participants |
| Start Date | 2022-05-23 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,050 participants in total. It began in 2022-05-23 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Wenhong Zhang, PHD
PRINCIPAL INVESTIGATOR
Huashan Hospital
Frequently Asked Questions
Who can join the NCT05081401 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 75 Years, studying Multidrug Resistant Tuberculosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05081401 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,050 participants.
Is NCT05081401 currently recruiting?
Yes, NCT05081401 is actively recruiting participants. Contact the research team at feng.sun@nmcid.org.cn for enrollment information.
Where is the NCT05081401 trial being conducted?
This trial is being conducted at Guiyang, China, Kaili, China, Liupanshui, China, Zunyi, China and 1 additional location.
Who is sponsoring the NCT05081401 clinical trial?
NCT05081401 is sponsored by Huashan Hospital. The principal investigator is Wenhong Zhang, PHD at Huashan Hospital. The trial plans to enroll 1,050 participants.