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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Short Course Regimen in Low Risk Active Tuberculosis- a Multicenter, Randomized, Active-controlled, Trial

Safety and Efficacy of Four-month Short Course Regimen in Low Risk Active Tuberculosis- a Multicenter Randomized Controlled Trial

Short Course Regimen in Low Risk Active Tuberculosis- a Multicenter, Randomized, Active-controlled, Trial (NCT06727864) is a Phase 3 interventional studying Pulmonary Tuberculosis, sponsored by Kaohsiung Veterans General Hospital.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Pulmonary Tuberculosis, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 270 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Pulmonary Tuberculosis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

4-month regimen (2HERZ/2HRE)

4-month (2HERZ/2HRE)

DRUG

6-month (2HERZ/4HRE)

2 months of HREZ followed by 4 months of HR/HRE

Locations (8)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06727864), the sponsor (Kaohsiung Veterans General Hospital.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06727864 clinical trial studying?

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 … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06727864?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06727864?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06727864. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06727864. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.