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

Last updated: March 21, 2025
Sponsor: Kaohsiung Veterans General Hospital.
Overall Status: Active - Recruiting

Phase

3

Condition

Hiv

Lung Disease

Treatment

4-month regimen (2HERZ/2HRE)

6-month (2HERZ/4HRE)

Clinical Study ID

NCT06727864
KSVGH24-CT2-16
  • Ages 20-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Newly diagnosed pulmonary tuberculosis patients combined with any of the followingdiagnostic conditions:

  • at least one set of sputum specimens is positive for Mycobacterium tuberculosisculture or TB PCR test; or

  • pathological and histological findings of typical tuberculosis manifestations;

  • clinical diagnosis and Physician determines the need for completeanti-tuberculosis treatment

  • Those who have had tuberculosis in the past and have been cured for at least threeyears 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 timesthe 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 creatinineclearance 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'surban treatment plan to ensure medication compliance.

Exclusion

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 clinicianjudges 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 systemtuberculosis, bone or joint tuberculosis, miliary tuberculosis or tuberculouspericarditis.

  • 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 ormore of the following drugs: rifampin, isoniazid, ethambutol

Study Design

Total Participants: 270
Treatment Group(s): 2
Primary Treatment: 4-month regimen (2HERZ/2HRE)
Phase: 3
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2028

Study 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

Connect with a study center

  • Far Eastern Memorial Hospital

    New Taipei, Bangiao 220
    Taiwan

    Active - Recruiting

  • Taichung Hospital

    Taichung, West 199
    Taiwan

    Active - Recruiting

  • E-DA Healthcare Group

    Kaoshiung, Yanchao 82445
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 80756
    Taiwan

    Active - Recruiting

  • Kaohsiung Veterans General Hospital

    Kaohsiung, 813
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital

    Taoyuan City, 333
    Taiwan

    Active - Recruiting

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