Short Course Regimen in Low Risk Active Tuberculosis- a Multicenter, Randomized, Active-controlled, Trial

Summary

Tuberculosis remains an important global health problem, and the world is currently not on track to end the TB epidemic by 2030. With the concerted efforts of the government and medical community, the incidence of TB in Taiwan has gradually decreased, however, Taiwan remains an endemic area for TB. The development of efficacious, safe, and shorter treatment regimens could significantly improve treatment completion rate and reduce transmission of TB. The current treatment guidelines for drug-susceptible TB from the World Health Organization (WHO), American Thoracic Society (ATS), United States Center for Diseases Control (U.S. CDC), Infectious Diseases Society of America (IDSA) and European Respiratory Society (ERS) include 2 months of isoniazid, rifampin, pyrazinamide and ethambutol (HREZ), followed by 4 months of isoniazid, rifampin, and ethambutol(HRE). The current treatment regimen requires 6 months of treatment, despite being highly efficacious, requires long duration of treatment. Adherence to treatment is the major barrier which poses a negative impact to TB control, and increased cost to both the patient and the public health system. Developing an efficacious, safe and short treatment regimen can significantly improve TB management and treatment success rates.

Conditions

• Pulmonary Tuberculosis

Interventions

DRUG

4-month regimen (2HERZ/2HRE)

4-month (2HERZ/2HRE)

DRUG

6-month (2HERZ/4HRE)

2 months of HREZ followed by 4 months of HR/HRE

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan

  collaborator OTHER_GOV

• National Taiwan University Hospital

  collaborator OTHER

• Chang Gung Memorial Hospital

  collaborator OTHER

• Far Eastern Memorial Hospital

  collaborator OTHER

• E-DA Hospital

  collaborator OTHER

• Kaohsiung Medical University

  collaborator OTHER

• Kaohsiung Veterans General Hospital.

  lead OTHER

Principal Investigators

• Susan Shin-Jung Lee, MD, PhD · Kaohsiung Veterans General Hospital.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2027-12-31

Completion

2028-12-31

Countries

• Taiwan

Study Locations