Active Screening of Latent TB Infection, Treatment and Long Term Follow-up in Prison

Phase 3

Completed

• Conditions: Tuberculosis
• Interventions: Drug: isoniazid , randomized, open label; Drug: rifampin, randomized, open label

• Registration Number: NCT00767975
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

LTBI Treatment is effective in prison

Detailed Description

LTBI treatment will be conducted in a prison with either isoniazid or rifampin

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-10-06
• Study First Posted: 2008-10-07
• Status Verified: 2010-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Last Update Submitted: 2010-11-25
• Last Update Posted: 2010-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 2384

Inclusion Criteria

• all people who is LTBI, and have ability to sign the informed concent

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Exclusion Criteria

• previously adverse effect from anti-TB medication complete treatment of TB in the pass; active TB AST, ALT > 3 times of normal limit platelet < 150 k/mm3 T-bil > 2 times of normal limit

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	isoniazid , randomized, open label	Provided INH 6m or RMP 4 m; whether enter treatment arm is determined by patient's willingness
1	rifampin, randomized, open label	Provided INH 6m or RMP 4 m; whether enter treatment arm is determined by patient's willingness

Primary Outcome Measures

Name	Time	Method
COMPLETE RATE OF LTBI TREATMENT	1.5 year

Secondary Outcome Measures

Name	Time	Method
Efficacy	3 year

Trial Locations

Locations (1)

Taipei Prison; 🇨🇳 Taoyuan, Taiwan