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

NCT04856644 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 333

Last updated 2024-07-12

No results posted yet for this study

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.

Conditions

  • Tuberculosis, Pulmonary

Interventions

DRUG

4-month rifapentine-based regimen

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

Sponsors & Collaborators

  • National Taiwan University

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • Centers for Disease Control, Taiwan

    collaborator OTHER_GOV

  • Kaohsiung Veterans General Hospital.

    lead OTHER

Principal Investigators

  • Susan Shin-Jung Lee, M.D., Ph.D. · Kaohsiung Veterans General Hospital.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04856644 on ClinicalTrials.gov