Status:
UNKNOWN
Toward a Safe and Reachable Preventive Therapy for LTBI: a Multicenter Randomized Controlled Study in Taiwan
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Latent Tuberculosis Infection
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 therap...
Detailed Description
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 therap...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Household contacts of TB or TB contacts in schools or densely-populated institutes
- Age ≥12 year-old
- Index case having smear-positive pulmonary TB
- Contact with index case for \>8 hours within single day or \>40 hours within total transmissible period
- TST ≥10 mm within one month
- Born in 1986 or after (not applicable in the National Taiwan University Hospital Hsin-Chu branch and Chang-Hua Hospital)
- Exclusion Criteria:
- Clinical or radiographic evidence of active TB
- Index case having culture-negative pulmonary TB
- Index case having Isoniazid or Rifampin-resistant TB
- Receiving medications with significant interactions with Isoniazid, Rifampin, or Rifapentine
- Allergy to Isoniazid, Rifampin, or Rifapentine
- Sero-positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Documented liver cirrhosis
- Human immunodeficiency virus (HIV) infection
- Receiving immunosuppressants
- Receiving biological agents
- Hemoglobin \<8 g/dL
- Neutrophil \<750000 /mL
- Total bilirubin \>2.5 mg/dL
- Aspartic transaminase (AST) or alanine transaminase (ALT) \>2 folds of upper limit of normal (ULN)
- Pregnant or breast-feeding
- Life expectancy \<3 years
Exclusion
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT02208427
Start Date
August 1 2014
End Date
December 1 2016
Last Update
December 15 2016
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100