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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age20-99
SponsorKaohsiung Veterans General Hospital.

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 4-month regimen (2HERZ/2HRE)
  • 6-month (2HERZ/4HRE)

Treatment groups

270 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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