Optimizing(O) RIfapentine-based(RI) Regimen and shortENing(EN) the Treatment of Drug-sensitive Tuberculosis(T)
Recruiting
Phase 2
Phase 3
Interventional Study
Tuberculosis, Pulmonary
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 2,442 (estimated)
- Sponsor
- Huashan Hospital · Other
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About This Trial
Tuberculosis (TB) remains the most important infectious disease in the world. A major barrier to tuberculosis control is poor adherence to long-term and complex treatment regimens.
This is a multicenter prospective, non-inferiority randomized controlled study. The purpose of our study is a) to evaluate the tolerability, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of the high-dose rifap…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age between 18 to 60 years;
* Weight between 40 to 80 kg;
* Individuals with smear-positive pulmonary tuberculosis and sensitive to rifampicin ;
* Willing to provide signed informed consent, or parental consent and participant assent.
* If you are a non-menopausal woman, agree…
Contacts