drugset / Trial / NCT05278988
A Study of Ultrashort PRS Regimen V in the Treatment of MDR-TB
Phase 4
Completed
60 enrolled
Shanghai Pulmonary Hospital, Shanghai, China
Anhui Chest Hospital · collabFourth Taiyuan People's Hospital, China · collabGanzhou Fifth People's Hospital, China · collabHuashan Hospital · collabNo.85 Hospital, Changning, Shanghai, China · collabShanghai Public Health Clinical Center · collabShanghai Pudong New Area Pulmonary Hospital, China · collabThe Sixth People's Hospital of Zhengzhou · collabWeifang Second People's Hospital, China · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an exploratory, prospective, randomized, active control, and open label clinical trial to evaluate the efficacy and safety of 6-9 months treatment with the ultrashort PRS Regimen V.
Timeline
- Start
- 2021-04-01
- Primary completion
- 2024-10-30
- Completion
- 2024-10-30
Publications
- Background Aung KJ, Van Deun A, Declercq E, Sarker MR, Das PK, Hossain MA, Rieder HL. Successful '9-month Bangladesh regimen' for multidrug-resistant tuberculosis among over 500 consecutive patients. Int J Tuberc Lung Dis. 2014 Oct;18(10):1180-7. doi: 10.5588/ijtld.14.0100.
- Background Van Deun A, Maug AK, Salim MA, Das PK, Sarker MR, Daru P, Rieder HL. Short, highly effective, and inexpensive standardized treatment of multidrug-resistant tuberculosis. Am J Respir Crit Care Med. 2010 Sep 1;182(5):684-92. doi: 10.1164/rccm.201001-0077OC. Epub 2010 May 4.
- Background Silva A, Lee BY, Clemens DL, Kee T, Ding X, Ho CM, Horwitz MA. Output-driven feedback system control platform optimizes combinatorial therapy of tuberculosis using a macrophage cell culture model. Proc Natl Acad Sci U S A. 2016 Apr 12;113(15):E2172-9. doi: 10.1073/pnas.1600812113. Epub 2016 Mar 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | — | — |
| Subject | Clofazimine | Small molecule | — | — |
| Subject | Delamanid | Small molecule | — | — |
| Subject | Pyrazinamide | Small molecule | — | — |