Actively Recruiting
Safety and Efficacy of Four-month Short Course Regimen in Low Risk Active Tuberculosis A Multicenter Randomized Controlled Trial
Led by Kaohsiung Veterans General Hospital. · Updated on 2025-03-25
270
Participants Needed
8
Research Sites
52 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 a significant global health challenge, and efforts to end the TB epidemic by 2030 are ongoing. In Taiwan, tuberculosis rates have declined, but the disease is still common. This research aims to evaluate whether a shorter, 4-month treatment course for low-risk, newly diagnosed pulmonary tuberculosis patients can be as effective and safe as the current standard 6-month regimen, potentially improving treatment completion and reducing costs and transmission. The study is a prospective, multicenter, randomized, open-label trial involving 270 adult participants. Patients will be randomly assigned to receive either a 4-month treatment of isoniazid, rifampin, pyrazinamide, and ethambutol for 2 months followed by 2 months of isoniazid, rifampin, and ethambutol, or the standard 6-month treatment with the same initial 2 months followed by 4 months of continuation therapy. The trial will last three years, with enrollment spread evenly across this period. Participants will be monitored through various time points for disease-free survival at 12 and 24 months after starting treatment, as well as for serious adverse events during treatment. Assessments include sputum culture conversion, blood tests measuring immune response markers, and mortality tracking. The study also evaluates the early sterilizing activity of the treatments and aims to ensure adherence through cooperation with public health programs. The overall participation includes treatment and follow-up visits up to two years post-treatment.
CONDITIONS
Brief 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 with at least one positive sputum culture or TB PCR test, typical pathological findings, or clinical diagnosis requiring full treatment
- Patients previously treated for tuberculosis who have been cured for at least three years
- Aged 20 years or older
- Laboratory tests within 14 days of enrollment showing ALT ≤ 3 times upper limit of normal
- Total bilirubin ≤ 2.5 times upper limit of normal
- Creatinine ≤ 2 times upper limit of normal or creatinine clearance > 30 mL/min
- Hemoglobin ≥ 7.0 g/dL
- Platelets ≥ 100,000/mm3
- Signed informed consent
- Agreement to cooperate with local health bureau treatment plans to ensure medication compliance
You will not qualify if you...
- Sputum acid-fast smear strongly positive (≥ 2+)
- Chest X-ray or lung CT showing open lesions or extensive disease judged unsuitable for short treatment
- Combined intrapulmonary and extrapulmonary tuberculosis
- Unable to take oral medications
- Previous participation in this study
- More than 14 days of anti-tuberculosis drug use prior to enrollment
- History or suspicion of central nervous system, bone or joint, miliary tuberculosis, or tuberculous pericarditis
- Known allergy or intolerance to study drugs
- HIV infection, organ transplantation, or chronic renal failure
- Long-term immunosuppressive drug use including steroids >10 mg/day for over 30 consecutive days in last three months
- Known resistance of Mycobacterium tuberculosis to rifampin, isoniazid, or ethambutol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 6 months
Participants receive either a 4-month or 6-month drug regimen for active tuberculosis.
Visits at weeks 2, 4, 8, 12, 16, 20, and 24 during treatment
Duration - Up to 24 months post-treatment
Participants are monitored for tuberculosis disease-free survival and other outcomes after treatment completion.
Visits at 3, 6, 12, and 24 months after treatment
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.
M
Mei-Ling Lin, University
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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