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New treatment option for Multidrug Resistant Tuberculosis
Official title Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
ClinicalTrials.gov ID: NCT05081401
What this study is testing
What is Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z?
Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for multidrug resistant tuberculosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 75
You may be able to join if
- 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...
- Signed informed consent form (ICF).
You likely can't join if
- Known allergies, hypersensitivity, or contraindication to any of the study drugs as described in additional material;
- 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;
- Patients who have received second-line MDR-TB treatment for 14 days or more prior to enrollment;
- Patients in critical condition and expected survival is estimated by physician to be less than 12 weeks.
The study team makes the final eligibility decision.
Where it's taking place
- Guiyang, Guizhou, China
- Kaili, Guizhou, China
- Liupanshui, Guizhou, China
- Zunyi, Guizhou, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guiyang, Guizhou, China; Kaili, Guizhou, China; Liupanshui, Guizhou, China; Zunyi, Guizhou, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.