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

National Taiwan University

Status and phase: Completed; Phase 3

Conditions: Tuberculosis

Treatments: Drug: isoniazid , randomized, open label; Drug: rifampin, randomized, open label

Study type: Interventional

Funder types: Other

Identifiers

NCT00767975

200707047M

DOH-97-DC-1502 (Other Grant/Funding Number)

Details and patient eligibility

About

LTBI Treatment is effective in prison

Full description

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

Enrollment: 2,384 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,384 participants in 2 patient groups

2

No Intervention group

Description:

For patients who diagnosed with LTBI, they choose to receive LTBI treatment depends on their willingness; if they choose not, then they are in no intervention arm.

1

Experimental group

Description:

Provided INH 6m or RMP 4 m; whether enter treatment arm is determined by patient's willingness

Treatment:

Drug: rifampin, randomized, open label

Drug: isoniazid , randomized, open label