Comparing Two Preventive Regimens for Latent Tuberculosis Infection (LTBI)

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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. 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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Isoniazid; Rifampin

Criteria

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