Short Course Regimen in Low Risk Active Tuberculosis- a Multicenter, Randomized, Active-controlled, Trial
Launched by KAOHSIUNG VETERANS GENERAL HOSPITAL. · Dec 6, 2024
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a shorter treatment plan for patients with low-risk pulmonary tuberculosis (TB). Currently, TB treatment typically lasts six months, which can be challenging for many people to complete. Researchers believe that a shorter, effective treatment could help more patients finish their medication, reduce the spread of TB, and lower healthcare costs. The trial aims to find out if this new treatment regimen is safe and effective for patients who are newly diagnosed with TB or have been cured of it for at least three years.
To participate in the trial, individuals must be over 20 years old and have a confirmed diagnosis of pulmonary TB, with specific lab results showing their health is stable. However, certain people are not eligible, such as those with severe symptoms or other serious health conditions. Participants can expect to receive the new treatment regimen and will need to work closely with healthcare professionals to ensure they take their medication as prescribed. This study is currently recruiting participants who meet the criteria and are willing to help improve TB treatment options for everyone.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- * Newly diagnosed pulmonary tuberculosis patients combined with any of the following diagnostic conditions:
- • 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:
- • The acid-fast smear of sputum or respiratory specimen is strongly positive (≥ 2+)
- • 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
About Kaohsiung Veterans General Hospital.
Kaohsiung Veterans General Hospital is a leading medical institution in Taiwan, renowned for its commitment to advancing healthcare through innovative clinical research and patient-centered care. As a prominent sponsor of clinical trials, the hospital combines cutting-edge medical technology with a team of experienced researchers and healthcare professionals dedicated to improving treatment outcomes and enhancing the quality of life for veterans and the broader community. With a focus on a wide range of therapeutic areas, Kaohsiung Veterans General Hospital actively contributes to the global medical research landscape, fostering collaboration and knowledge exchange to drive significant advancements in clinical practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Kaohsiung, , Taiwan
Taipei, , Taiwan
Kaohsiung, , Taiwan
Taoyuan City, , Taiwan
Taipei, , Taiwan
New Taipei, Bangiao, Taiwan
Taichung, West, Taiwan
Kaoshiung, Yanchao, Taiwan
Patients applied
Trial Officials
Susan Shin-Jung Lee, MD, PhD
Principal Investigator
Kaohsiung Veterans General Hospital.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported