Shorter treatment for low-risk active tuberculosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Far Eastern Memorial Hospital
  New Taipei City, Bangiao, Taiwan Recruiting
• Taichung Hospital
  Taichung, West, Taiwan Recruiting
• E-DA Healthcare Group
  Kaohsiung City, 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

Study contacts

• Principal investigator: Susan Shin-Jung Lee, MD, PhD — Kaohsiung Veterans General Hospital.
• Study coordinator: Susan Shin-Jung Lee, M.D., Ph.D.
• Email: ssjlee28@yahoo.com.tw
• Phone: +886-7342-2121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.