Toward a Safe and Reachable Preventive Therapy for LTBI: a Multicenter Randomized Controlled Study in Taiwan
Status:
Unknown status
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
Background:
Tuberculosis (TB) remains the most important infectious disease in the world. Keys to
successful control of TB is rapid diagnosis, prompt treatment, as well as effective
preventive therapy for contacts with latent TB infection (LTBI). Current methods for the
diagnosis of LTBI are tuberculin skin test (TST) and interferon-gamma release assay (IGRA).
For preventive therapy, the recommended regimens include daily isoniazid for 9 months and
daily rifampicin for 4 months. By incorporating long-acting rifapentine, a new regimen
combining weekly rifapentine and high-dose isoniazid for a total of 12 doses has been proven
of equal potency and toxicity. However, the treatment completion rate is much higher in
weekly treatment for 3 months than daily treatment for 9 months. It is reasonable that using
rifapentine-based preventive therapy can markedly increase the completion rate. However,
study is lacking, especially in Asia, the high endemic area of TB.
With the effort of all health care workers and public health personnel, the incidence of TB
in Taiwan has gradually declined in recent 10 years. In order to maintain the trend of
decreasing in incidence, preventive therapy for LTBI become more and more important. However,
which is the best preventive regimen for LTBI is still unknown. Therefore, we conduct the
prospective randomized multicenter studies to compare the treatment completion rate of two
regimens in Taiwan. The first regimen is daily isoniazid for 9 months. The second is weekly
rifapentine plus high-dose isoniazid for 3 months.