Short Course Regimen in Low Risk Active Tuberculosis- a Multicenter, Randomized, Active-controlled, Trial
NCT ID: NCT06727864
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
270 participants
INTERVENTIONAL
2024-01-01
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Short Regimen for Rifampicin-resistant Isoniazid-susceptible TB
NCT06526039
Toward a Safe and Reachable Preventive Therapy for LTBI: a Multicenter Randomized Controlled Study in Taiwan
NCT02208427
Evaluation of the Efficacy and Safety of a 4-month Daily Regimen (2HZPM/2HPM) for Treatment of Pulmonary TB
NCT04856644
Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment
NCT04655794
Efficacy of HUEXC030 in Subjects With Pulmonary Tuberculosis
NCT02467608
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study aims to evaluate the efficacy, safety and long-term recurrence rate of a short-course, 4-months regimen including 2HREZ/2HRE compared with the standard 6-months regimen, 2HREZ/4HRE, and the impact of short regimen on reducing the costs and loading to the public health and medical system
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention/Treatment
Two months of isoniazid (H), ethambutol (E), rifampicin (R) and Pyrazinamide (Z) followed by HR(E) for another two months
4-month regimen (2HERZ/2HRE)
4-month (2HERZ/2HRE)
6-months HERZ (2HERZ/4HRE)
Two months of isoniazid (H), pyrazinamide (Z), rifampicin (R) and Pyrazinamide (Z) followed by HR(E) for another four months
6-month (2HERZ/4HRE)
2 months of HREZ followed by 4 months of HR/HRE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
4-month regimen (2HERZ/2HRE)
4-month (2HERZ/2HRE)
6-month (2HERZ/4HRE)
2 months of HREZ followed by 4 months of HR/HRE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* at least one set of sputum specimens is positive for Mycobacterium tuberculosis culture or TB PCR test; or
* pathological and histological findings of typical tuberculosis manifestations;
* clinical diagnosis and Physician determines the need for complete anti-tuberculosis treatment
* Those who have had tuberculosis in the past and have been cured for at least three years can be included
* Aged over 20 years old
* Laboratory data at the time of inclusion in the study or within 14 days:
* Serum or plasma glutamic acid pyruvate transaminase (ALT) value ≦ three times the upper limit of normal
* Serum or plasma total bilirubin ≦ 2.5 times the upper limit of normal
* Serum or plasma creatinine ≦ twice the upper limit of normal or creatinine clearance greater than 30 mL/min
* Heme ≧7.0 g/Dl
* Platelets ≧100,000/mm3
* Patient signs consent form
* Patients who agree to join and cooperate with the county and city health bureau's urban treatment plan to ensure medication compliance.
Exclusion Criteria
* Chest X-ray or lung computed tomography combined with open lesions
* Chest X-ray or lung computed tomography shows extensive lesions and the clinician judges that short-term treatment is not suitable
* Simultaneous combination of intrapulmonary and extrapulmonary tuberculosis
* People who are unable to take oral medications
* People who have participated in this research
* Have used anti-tuberculosis drugs for more than 14 days
* A history of tuberculosis suspected or diagnosed as central nervous system tuberculosis, bone or joint tuberculosis, miliary tuberculosis or tuberculous pericarditis.
* Known history of allergy or intolerance to this study drug
* Patients with HIV infection, organ transplantation, and chronic renal failure
* Long-term use of immunosuppressive drugs, including steroid use \>10mg/day (more than 30 consecutive days in the last three months)
* Late exclusion: Mycobacterium tuberculosis is known to be resistant to any one or more of the following drugs: rifampin, isoniazid, ethambutol
20 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
National Taiwan University Hospital
OTHER
Chang Gung Memorial Hospital
OTHER
Far Eastern Memorial Hospital
OTHER
E-DA Hospital
OTHER
Kaohsiung Medical University
OTHER
Kaohsiung Veterans General Hospital.
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Susan Shin-Jung Lee
Attending physician
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Susan Shin-Jung Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Veterans General Hospital.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Far Eastern Memorial Hospital
New Taipei City, Bangiao, Taiwan
Taichung Hospital
Taichung, West, Taiwan
E-DA Healthcare Group
Kaoshiung, Yanchao, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Hsin-Wei Tung, R.N.
Role: backup
Jia-Yih Feng, M.D.
Role: primary
Chin-Chung Shu, M.D.
Role: primary
Tsai-Yu Wang, M.D.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KSVGH24-CT2-16
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.