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.
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
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
Parallel
4-month regimen (2HERZ/2HRE)
Drug4-month (2HERZ/2HRE)
6-month (2HERZ/4HRE)
Drug2 months of HREZ followed by 4 months of HR/HRE
TB disease free survival at 12 months post-randomization
Number of participants without TB disease at 12 months after randomization
TB disease free survival at 24 months post randomization
Number of participants without TB disease at 24 months after randomization
Grade 3-5 adverse events
Development of Grade3-5 adverse events during treatment
Early sterilizing activity
The proportion of patients with a negative sputum culture at the end of intensive phase therapy at 8 weeks
Sputum culture conversion
Time to stable sputum culture conversion
All-cause mortality
All-cause mortality at 4 months and 12 months post-treatment assignment
Attributable mortality
Attributable mortality at 4 months and 12 months post-treatment assignment
HLA associations with severe drug adverse events
HLA Genotyping to detect predictors for occurrence of severe drug adverse events including skin rash and hepatitis.
Click on the lead sponsor to view all of their trials.
Kaohsiung Veterans General Hospital.
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Collaborator
National Taiwan University Hospital
Collaborator
Chang Gung Memorial Hospital
Collaborator
Far Eastern Memorial Hospital
Collaborator
E-DA Hospital
Collaborator
Kaohsiung Medical University
Collaborator
