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NCT06727864RecruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 3 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
270 (estimated)
First submitted
6 Dec 2024
Start date
1 Jan 2024
Primary completion date
31 Dec 2027
Lead sponsor
Kaohsiung Veterans General Hospital.
Diseases
Tuberculosis
NCT number
NCT06727864

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 270
  • From 1 Jan 2024 to the primary completion date, 31 Dec 2027
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • People who are unable to take oral medications
  • Long-term use of immunosuppressive drugs, including steroid use \>10mg/day (more than 30 consecutive days in the last three months)

Other illness

  • Simultaneous combination of intrapulmonary and extrapulmonary tuberculosis
  • 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
  • Late exclusion: Mycobacterium tuberculosis is known to be resistant to any one or more of the following drugs: rifampin, isoniazid, ethambutol

Other

  • 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
  • People who have participated in this research

Who the study is looking for

  • 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.

Age in the registry: 20 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
E-DA Healthcare Group
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanRecruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanRecruiting
Kaohsiung Veterans General Hospital
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanRecruiting
Far Eastern Memorial Hospital
Coordinator of this site? Confirm its status
New Taipei CityTaiwanRecruiting
Taichung Hospital
Coordinator of this site? Confirm its status
TaichungTaiwanRecruiting
Taipei Veterans General Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
National Taiwan University Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
Linkou Chang-Gung Memorial Hospital
Coordinator of this site? Confirm its status
Taoyuan CityTaiwanRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.