Status:
COMPLETED
Risk of SDRs Under 3HP and 1HP Regimen for LTBI
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Latent Tuberculosis Infection
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
Successful implement of preventive therapy for subjects with latent tuberculosis infection (LTBI) is the critical step for elimination of tuberculosis (TB). The major obstacle of traditional preventiv...
Detailed Description
Tuberculosis (TB) remains one of the deadliest infectious diseases, with an estimated 10.0 million new cases and 1.6 million deaths in 2017. The World Health Organization (WHO) has set the goal of eli...
Eligibility Criteria
Inclusion
- aged ≥12 years
- close contact (defined as unprotected exposure of ≥8 hours in a single day or a cumulative duration of ≥40 hours, as per the national policy of Taiwan) with patients diagnosed with acid-fast smear (AFS)-positive pulmonary TB
- diagnosed with LTBI using either a tuberculin skin test (TST) or QuantiFERON-TB Gold in-tube assay (QFT; Cellestis/Qiagen, Carnegie, Australia)
Exclusion
- suspected to have active pulmonary TB because of their clinical symptoms or chest radiography findings
- concurrently using drugs with severe drug-drug interactions
- allergic to INH, rifampin, or RPT
- a life expectancy \<3 years
Key Trial Info
Start Date :
September 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
490 Patients enrolled
Trial Details
Trial ID
NCT04094012
Start Date
September 24 2019
End Date
December 15 2023
Last Update
December 26 2023
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 10002