MedTrace Logo

A Short Regimen for Rifampicin-resistant Isoniazid-susceptible TB

NCT06526039 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-07-29

No results posted yet for this study

Summary

To assess outcome of treatment and safety among patients with rifampicin-resistant isoniazid-susceptible pulmonary tuberculosis treated with a novel regimen consisting of isoniazid, bedaquiline, and moxifloxacin throughout for 6 months, supplemented by pyrazinamide for the initial 2 months.

Conditions

  • Tuberculosis, Pulmonary

Interventions

OTHER

a novel short regimen

An intensive phase consisting of isoniazid, bedaquiline, moxifloxacin and pyrazinamide for 2 months (9 weeks). A continuation phase consisting of isoniazid, bedaquiline, and levofloxacin for 4 months (17 weeks). Treatment may be extended for 3 months (13 weeks) in patients with severe disease or with delayed culture conversion, defined by culture positive at 4 months of treatment.

Sponsors & Collaborators

  • Hualien Tzu Chi General Hospital

    collaborator OTHER

  • Chest Hospital, Ministry of Health and Welfare, Taiwan

    collaborator OTHER_GOV

  • Chang-Hua Hospital

    collaborator OTHER_GOV

  • Taichung Veterans General Hospital

    collaborator OTHER

  • Taichung Hospital, Ministry of Health and Welfare

    collaborator UNKNOWN

  • Taoyuan General Hospital

    collaborator OTHER_GOV

  • Kaohsiung Veterans General Hospital.

    collaborator OTHER

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    collaborator OTHER

  • Taipei Medical University WanFang Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2028-12-31
Completion
2029-12-31

More Related Trials

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 NCT06526039 on ClinicalTrials.gov