Status:
UNKNOWN
Comparing Two Preventive Regimens for Latent Tuberculosis Infection (LTBI)
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Latent Tuberculosis Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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. Howe...
Detailed Description
In countries with a low incidence of tuberculosis (TB), most new, active cases have occurred among persons who were once infected, contained this infection, and then later developed active TB. Therefo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01398618
Start Date
May 1 2011
End Date
December 1 2013
Last Update
July 20 2011
Active Locations (2)
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1
Chest Hospital, Department of Health, Executive Yuan
Tainan, Taiwan, 71742
2
National Taiwan University Hospital
Taipei, Taiwan, 100