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

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

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