NCT05278988

A Study of Ultrashort PRS Regimen V in the Treatment of MDR-TB

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Shortening the course of treatment based on effective therapy can significantly improve patient compliance and reduce the public health burden.Research on optimal drug combination regimens to further shorten the duration and improve the efficacy of multidrug-resistant tuberculosis treatment is an important research direction.The PRS (parabolic response surface, FSC.II) system is an enhanced use of FSC to better identify and optimize optimal drug combinations.In preliminary studies, it was determined that PRS Regimens V （bedaquiline, delamanid, clofazimine, pyrazinamide）was superior to other regimens and would be a promising combination for XDR-TB because it does not contain fluoroquinolones or aminoglycosides. Preliminary trials have demonstrated that this regimen (PRS Regimens IV) can significantly reduce the duration of treatment required for MDR-TB and achieve a relapse-free cure. Therefore, the investigators conducted an exploratory, prospective, randomized, positive-controlled, open, multicenter clinical study of this new regimen to observe the efficacy, safety, and recent relapse rate of the new regimen in the treatment of multidrug-resistant tuberculosis.

Conditions

• MDR-TB

Interventions

Type	Name	Description
DRUG	PRS Regimen V	PRS Regimen V(bedaquiline, delamanid, clofazimine, pyrazinamide)
DRUG	MDR-TB Treatment Regimen(WHO)	Treatment according to WHO MDR-TB treatment guidelines (2019)

Timeline

• Start date: 2021-04-01
• Primary completion: 2024-10-30
• Completion: 2024-10-30
• First posted: 2022-03-15
• Last updated: 2024-12-03

Locations

1 site across 1 country: China