Actively Recruiting

Phase 3
Age: 20Years - 99Years
All Genders
NCT06727864

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

Led by Kaohsiung Veterans General Hospital. · Updated on 2025-03-25

270

Participants Needed

8

Research Sites

260 weeks

Total Duration

On this page

Sponsors

K

Kaohsiung Veterans General Hospital.

Lead Sponsor

T

Taipei Veterans General Hospital, Taiwan

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 20Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed pulmonary tuberculosis patients confirmed by sputum culture, TB PCR, pathology, or clinical diagnosis
  • Patients previously treated for tuberculosis with cure at least three years prior
  • Age 20 years or older
  • Laboratory values within normal limits for liver enzymes, bilirubin, kidney function, hemoglobin, and platelets
  • Signed consent form
  • Agree to cooperate with local health treatment plans to ensure medication compliance
Not Eligible

You will not qualify if you...

  • Strongly positive acid-fast sputum smear (≥ 2+)
  • Chest X-ray or CT showing open or extensive lung lesions unsuitable for short-term treatment
  • Concurrent intrapulmonary and extrapulmonary tuberculosis
  • Unable to take oral medications
  • Previous participation in this study
  • Use of anti-tuberculosis drugs for more than 14 days
  • History of central nervous system, bone/joint, miliary tuberculosis, or tuberculous pericarditis
  • Known allergy or intolerance to study drugs
  • HIV infection, organ transplantation, or chronic renal failure
  • Long-term use of immunosuppressive drugs including steroids >10mg/day for over 30 days in past 3 months
  • Presence of drug-resistant Mycobacterium tuberculosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Far Eastern Memorial Hospital

New Taipei City, Bangiao, Taiwan, 220

Actively Recruiting

2

Taichung Hospital

Taichung, West, Taiwan, 199

Actively Recruiting

3

E-DA Healthcare Group

Kaoshiung, Yanchao, Taiwan, 82445

Actively Recruiting

4

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 80756

Actively Recruiting

5

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan, 813

Actively Recruiting

6

Taipei Veterans General Hospital

Taipei, Taiwan, 112

Actively Recruiting

7

National Taiwan University Hospital

Taipei, Taiwan

Actively Recruiting

8

Linkou Chang Gung Memorial Hospital

Taoyuan City, Taiwan, 333

Actively Recruiting

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Research Team

S

Susan Shin-Jung Lee, M.D., Ph.D.

CONTACT

M

Mei-Ling Lin, University

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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