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ACTIVE NOT RECRUITING
NCT04856644
PHASE3

Evaluation of the Efficacy and Safety of a 4-month Daily Regimen (2HZPM/2HPM) for Treatment of Pulmonary TB

Sponsor: Kaohsiung Veterans General Hospital.

View on ClinicalTrials.gov

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.

Official title: Evaluation of the Efficacy and Safety of a Short-course, Daily, 4-month Regimen Including Isoniazid, Pyrazinamide, Rifapentine and Moxifloxacin (2HZPM/2HPM) for the Treatment of Drug-susceptible Pulmonary Tuberculosis in Taiwan (ESCAPE-TB)

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

333

Start Date

2020-01-01

Completion Date

2024-12-31

Last Updated

2024-07-12

Healthy Volunteers

No

Interventions

DRUG

4-month rifapentine-based regimen

8 weeks of isoniazid, pyrazinamide, rifapentine, and moxifloxacin, followed by 9 weeks of isoniazid, rifapentine and moxifloxacin

Locations (4)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan