Shorter treatment for low-risk active tuberculosis

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

This study is testing if a shorter 4-month treatment for low-risk pulmonary tuberculosis works just as well as the usual 6-month treatment for newly diagnosed patients.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 270 (estimated)
• Ages: 20 Years to 99 Years
• Sex: All
• Sponsor: Kaohsiung Veterans General Hospital. (other)
• Locations: 8 sites (New Taipei City, Bangiao and 7 other locations)
• Trial ID: NCT06727864 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized trial aims to evaluate the efficacy and safety of a 4-month treatment regimen for newly diagnosed low-risk pulmonary tuberculosis patients, compared to the standard 6-month regimen. The study will enroll 270 adult participants who will be randomly assigned to receive either the shorter or the standard treatment. The primary focus is on assessing sputum conversion rates, recurrence rates, and the overall impact on public health and healthcare costs. The trial will take place over three years, with 90 patients expected to be enrolled each year.

Who should consider this trial

Good fit: Ideal candidates include adults over 20 years old with newly diagnosed pulmonary tuberculosis and low risk of recurrence.

Not a fit: Patients with a history of tuberculosis who have not been cured for at least three years or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a more effective and shorter treatment option for tuberculosis, improving patient adherence and reducing transmission.

How similar studies have performed: Previous studies have shown promise in shorter treatment regimens for tuberculosis, indicating potential for success in this approach.

Eligibility criteria

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

Where this trial is running

New Taipei City, Bangiao and 7 other locations

• Far Eastern Memorial Hospital — New Taipei City, Bangiao, Taiwan (RECRUITING)
• Taichung Hospital — Taichung, West, Taiwan (RECRUITING)
• E-DA Healthcare Group — Kaoshiung, Yanchao, Taiwan (RECRUITING)
• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (RECRUITING)
• Kaohsiung Veterans General Hospital — Kaohsiung City, Taiwan (RECRUITING)
• Taipei Veterans General Hospital — Taipei, Taiwan (RECRUITING)
• National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)
• Linkou Chang Gung Memorial Hospital — Taoyuan City, Taiwan (RECRUITING)

Study contacts

• Principal investigator: Susan Shin-Jung Lee, MD, PhD — Kaohsiung Veterans General Hospital.
• Study coordinator: Susan Shin-Jung Lee, M.D., Ph.D.

Conditions: Pulmonary Tuberculosis, tuberculosis, short course regimen, safety, sputum conversion, recurrence rate