Actively Recruiting
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
Eligibility Criteria
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
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
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
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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