drugset / Trial / NCT04856644
Evaluation of the Efficacy and Safety of a 4-month Daily Regimen (2HZPM/2HPM) for Treatment of Pulmonary TB
Phase 3
Active not recruiting
333 enrolled
Kaohsiung Veterans General Hospital.
Centers for Disease Control, Taiwan · collabChang Gung Memorial Hospital · collabNational Taiwan University · collabTaipei Veterans General Hospital, Taiwan · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The development of efficacious, safe, and shorter treatment regimens could significantly improve TB management and treatment success rates. This prospective, 3-year, single arm study is to evaluate the efficacy and safety of a short-course, 4-month regimen including isoniazid(H), pyrazinamide(P), rifapentine (P), and moxifloxacin(M) (2HZPM/2HPM) for the treatment of drug-susceptible, pulmonary tuberculosis, and compared with a historical control group receiving the standard six-month regimen.
Timeline
- Start
- 2020-01-01
- Primary completion
- 2023-12-31
- Completion
- 2024-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isoniazid | Small molecule | — | — |
| Subject | Moxifloxacin | Small molecule | — | — |
| Subject | Rifapentine | Small molecule | — | — |
| Background | Pyrazinamide | Small molecule | — | — |