Pulmonary TuberculosisPhase 3NCT06727864
Short Course Regimen in Low Risk Active Tuberculosis- a Multicenter, Randomized, Active-controlled, Trial
A Phase 3 study testing 4-month regimen (2HERZ/2HRE) and 6-month (2HERZ/4HRE) in people with Pulmonary Tuberculosis, run by Kaohsiung Veterans General Hospital. at 8 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- 4-month regimen (2HERZ/2HRE) and 6-month (2HERZ/4HRE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 8 sitesTaiwan
- Study dates
- 1 Jan 2024to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Taiwan8 sites, 8 recruiting
- Recruiting
E-DA Healthcare Group
Kaohsiung City, Yanchao, 82445
Lee Ho-Sheng PhD, PhD, 07-6150011 ext. 07-6150011, leehoshn@gmail.com
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Chau-Chyun Sheu, M.D. Ph.D., +886-7312-1101, sheu@kmu.edu.tw
- Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City, 813
Susan Shin-Jung Lee, M.D., Ph.D., +886-7342-2121 ext. 2029, ssjlee28@yahoo.com.tw
Hsin-Wei Tung, R.N., +886-73422121 ext. 2062
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, Bangiao, 220
Wang Ping-Huai PhD, PhD, 02-9866-7000 ext. 02-9866-7000, pinghuaiwang@gmail.com
- Recruiting
Taichung Hospital
Taichung, West, 199
Huang Jhong-Ru PhD, PhD, 04-222294411 ext. 04-222294411, pcipur@gmail.com
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Jia-Yih Feng, M.D., +886-2871-2121 ext. 7564
Jia-Yih Feng, M.D.
- Recruiting
National Taiwan University Hospital
Taipei
Chin-Chung Shu, M.D., +886-2312-3456 ext. 65132
Chin-Chung Shu, M.D.
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan City, 333
Tsai-Yu Wang, M.D., +886-3-3281200 ext. 8470
Tsai-Yu Wang, M.D.
About this study
Official title: Safety and Efficacy of Four-month Short Course Regimen in Low Risk Active Tuberculosis- a Multicenter Randomized Controlled Trial
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.
Read the detailed description
This prospective, multicenter, randomized, open-labeled 3-year study, will recruit 270 adult patients with newly diagnosed tuberculosis with low risk of recurrence, and randomized 1:1 to a 4 months 2HREZ/2HRE (n=135) versus standard, 6 months regimen 2HREZ/4HRE (n=135). Expected enrollment will be 90 patients in year 1, 90 in year 2 and 90 in year 3.
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
- Pulmonary Tuberculosis
- Being tested
- 4-month regimen (2HERZ/2HRE), 6-month (2HERZ/4HRE)
- Keywords
- tuberculosis, short course regimen, safety, sputum conversion, recurrence rate
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-month regimen (2HERZ/2HRE)Drug
4-month (2HERZ/2HRE)
6-month (2HERZ/4HRE)Drug
2 months of HREZ followed by 4 months of HR/HRE
| Study group | Role | What they receive |
|---|---|---|
| Intervention/Treatment | Experimental | Two months of isoniazid (H), ethambutol (E), rifampicin (R) and Pyrazinamide (Z) followed by HR(E) for another two months Receives: Drug: 4-month regimen (2HERZ/2HRE) |
| 6-months HERZ (2HERZ/4HRE) | Active comparator | Two months of isoniazid (H), pyrazinamide (Z), rifampicin (R) and Pyrazinamide (Z) followed by HR(E) for another four months Receives: Drug: 6-month (2HERZ/4HRE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
TB disease free survival at 12 months post-randomization
Number of participants without TB disease at 12 months after randomization
Measured: 12 months
TB disease free survival at 24 months post randomization
Number of participants without TB disease at 24 months after randomization
Measured: 24 months
Grade 3-5 adverse events
Development of Grade3-5 adverse events during treatment
Measured: From enrollment to the end of treatment at 4 or 6 months
Secondary outcomes (8)
Early sterilizing activity
The proportion of patients with a negative sputum culture at the end of intensive phase therapy at 8 weeks
Measured: 8 weeks
Sputum culture conversion
Time to stable sputum culture conversion
Measured: 4, 8, 12, 16,20,24 weeks,3, 6, 12 and 24 months after treatment
All-cause mortality
All-cause mortality at 4 months and 12 months post-treatment assignment
Measured: 4, 12 months
Attributable mortality
Attributable mortality at 4 months and 12 months post-treatment assignment
Measured: 4, 12 months
Changes in interferon-gamma levels
Changes in interferon-gamma levels during treatment compared to baseline
Measured: 2, 4, 8, 12,16or 24 weeks
Changes in tumor necrosis factor-alpha levels
Changes in tumor necrosis factor-alpha levels during treatment compared to baseline
Measured: 2, 4, 8, 12,16or 24 weeks
Changes in interleukin-12 and interleukin-6 levels
Changes in interleukin-12 and interleukin-6 levels during treatment compared to baseline
Measured: 2, 4, 8, 12,16or 24 weeks
Changes in triggering receptor expressed on myeloid cells-1 (TREM-1) levels
Changes in triggering receptor expressed on myeloid cells-1 (TREM-1) levels during treatment compared to baseline
Measured: 2, 4, 8, 12,16or 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two months of isoniazid (H), pyrazinamide (Z), rifampicin (R), and pyrazinamide (Z) Subsequent orders are for H(E)Z for another two months
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, National Taiwan University Hospital, Chang Gung Memorial Hospital, Far Eastern Memorial Hospital, E-DA Hospital, Kaohsiung Medical University
- Responsible party
- Principal investigator, Susan Shin-Jung Lee, Kaohsiung Veterans General Hospital.
- Investigators
- Susan Shin-Jung Lee, MD, PhD, Principal investigator, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727864
- Sponsor's protocol ID
- KSVGH24-CT2-16
- Status last verified
- Jul 2026
- First submitted
- 6 Dec 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Four-month Short Course Regimen in Low Risk Active Tuberculosis- a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06727864
- Acronym / sponsor ID
- KSVGH24-CT2-16
- Conditions
- Pulmonary Tuberculosis
- Keywords
- tuberculosis, short course regimen, safety, sputum conversion, recurrence rate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, National Taiwan University Hospital, Chang Gung Memorial Hospital, Far Eastern Memorial Hospital, E-DA Hospital, Kaohsiung Medical University
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective, multicenter, randomized, open-labeled 3-year study, will recruit 270 adult patients with newly diagnosed tuberculosis with low risk of recurrence, and randomized 1:1 to a 4 months 2HREZ/2HRE (n=135) versus standard, 6 months regimen 2HREZ/4HRE (n=135). Expected enrollment will be 90 patients in year 1, 90 in year 2 and 90 in year 3.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two months of isoniazid (H), pyrazinamide (Z), rifampicin (R), and pyrazinamide (Z) Subsequent orders are for H(E)Z for another two months
| Arm | Type | Receives |
|---|---|---|
| Intervention/Treatment | Experimental | Drug: 4-month regimen (2HERZ/2HRE)Two months of isoniazid (H), ethambutol (E), rifampicin (R) and Pyrazinamide (Z) followed by HR(E) for another two months |
| 6-months HERZ (2HERZ/4HRE) | Active comparator | Drug: 6-month (2HERZ/4HRE)Two months of isoniazid (H), pyrazinamide (Z), rifampicin (R) and Pyrazinamide (Z) followed by HR(E) for another four months |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Newly diagnosed pulmonary tuberculosis patients combined with any of the following diagnostic conditions:
- 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:
- Patient signs consent form
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4-month regimen (2HERZ/2HRE)4-month (2HERZ/2HRE) | Drug | Intervention/Treatment |
| 6-month (2HERZ/4HRE)2 months of HREZ followed by 4 months of HR/HRE | Drug | 6-months HERZ (2HERZ/4HRE) |
Primary outcome
TB disease free survival at 12 months post-randomization
Time frame: 12 months
Number of participants without TB disease at 12 months after randomization
TB disease free survival at 24 months post randomization
Time frame: 24 months
Number of participants without TB disease at 24 months after randomization
Grade 3-5 adverse events
Time frame: From enrollment to the end of treatment at 4 or 6 months
Development of Grade3-5 adverse events during treatment
8 secondary outcomes
Early sterilizing activity
Time frame: 8 weeks
Sputum culture conversion
Time frame: 4, 8, 12, 16,20,24 weeks,3, 6, 12 and 24 months after treatment
All-cause mortality
Time frame: 4, 12 months
Attributable mortality
Time frame: 4, 12 months
Changes in interferon-gamma levels
Time frame: 2, 4, 8, 12,16or 24 weeks
Changes in tumor necrosis factor-alpha levels
Time frame: 2, 4, 8, 12,16or 24 weeks
Changes in interleukin-12 and interleukin-6 levels
Time frame: 2, 4, 8, 12,16or 24 weeks
Changes in triggering receptor expressed on myeloid cells-1 (TREM-1) levels
Time frame: 2, 4, 8, 12,16or 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan Shin-Jung Lee, MD, PhD principal investigator
Kaohsiung Veterans General Hospital.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 4-month regimen (2HERZ/2HRE) and 6-month (2HERZ/4HRE) in people with Pulmonary Tuberculosis, run by Kaohsiung Veterans General Hospital. at 8 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Shin-Jung Lee, M.D., Ph.D. (+886-7342-2121 ext. 72029, ssjlee28@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TB disease free survival at 12 months post-randomization (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.