Latent Tuberculosis Infection Clinical Trial
Official title:
Comparing the Efficacy of Two Preventive Regimens for Adult Household Contacts With Latent Tuberculosis Infection
Verified date | June 2011 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
Though still an endemic area, the incidence of tuberculosis (TB) in Taiwan is decreasing in
recent years. Further reduction in TB incidence, or even elimination should rely on
treatment for LTBI. However, which is the cost-effective screening method or what is the
cost-effective regimen in Taiwan is still unclear.
Therefore, the investigators designed this prospective study to follow up adult household
contacts with LTBI for 2 years and compare the efficacy of 9-month isoniazid and 4-month
rifampicin).
Status | Active, not recruiting |
Enrollment | 300 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - household contact of patients with newly diagnosed, culture-confirmed pulmonary tuberculosis - age > 18 - tuberculin skin testing-positive or QuantiFERON-positive - hemoglobin > 8 g/dL - neutrophil > 750 /uL - total bilirubin < 2.5 mg/dL - aspartic and alanine transaminases < 2 times of upper limit of normal - willing to receive serology tests for HBV and HCV infection - no history of allergy to isoniazid and rifampin - not currently pregnant or breast-feeding Exclusion Criteria: - the M. tuberculosis isolate of the index case were isoniazid- or rifampin-resistant - liver cirrhosis - clinical or radiographical evidence of active tuberculosis - active hepatitis - currently receiving medication that have documented drug interaction with isoniazid or rifampin - life expectancy < 3 years |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Taiwan | Chest Hospital, Department of Health, Executive Yuan | Tainan | |
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants developing active tuberculosis | every 6 months for 2 years | No | |
Secondary | the sensitivity and specificity of tuberculin-skin-testing and QuantiFERON TB-Gold assay for the development of active pulmonary tuberculosis | Sensitivity: No. of participants who were test-positive among all participants who developed active pulmonary tuberculosis Specificity: No. of participants who were test-negative among all participants who did not develop active pulmonary tuberculosis |
Every 6 months for 2 years | No |
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