Short Course Regimen in Low Risk Active Tuberculosis- a Multicenter, Randomized, Active-controlle… (NCT06727864) | Clinical Trial Compass
RecruitingPhase 3
Short Course Regimen in Low Risk Active Tuberculosis- a Multicenter, Randomized, Active-controlled, Trial
Taiwan270 participantsStarted 2024-01-01
Plain-language summary
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.
Who can participate
Age range
20 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 extrap…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
TB disease free survival at 12 months post-randomization
Timeframe: 12 months
2
TB disease free survival at 24 months post randomization
Timeframe: 24 months
3
Grade 3-5 adverse events
Timeframe: From enrollment to the end of treatment at 4 or 6 months