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

NCT ID: NCT00767975

Last Updated: 2010-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2384 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-11-30

Brief Summary

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LTBI Treatment is effective in prison

Detailed Description

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

Conditions

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Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

1

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

Group Type EXPERIMENTAL

isoniazid , randomized, open label

Intervention Type DRUG

isoniazid 300mg/tab 1 tab qd, 6 months (the other treatment arm is rifampin)

rifampin, randomized, open label

Intervention Type DRUG

rifampin 300mg/capsule 2 caps qd, 4 months (the other treatment arm is isoniazid)

Interventions

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isoniazid , randomized, open label

isoniazid 300mg/tab 1 tab qd, 6 months (the other treatment arm is rifampin)

Intervention Type DRUG

rifampin, randomized, open label

rifampin 300mg/capsule 2 caps qd, 4 months (the other treatment arm is isoniazid)

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University Hospital

Principal Investigators

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Li-Min Huang, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

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Taipei Prison

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

References

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Chan PC, Yang CH, Chang LY, Wang KF, Lu BY, Lu CY, Shao PL, Hsueh PR, Fang CT, Huang LM. Latent tuberculosis infection treatment for prison inmates: a randomised controlled trial. Int J Tuberc Lung Dis. 2012 May;16(5):633-8. doi: 10.5588/ijtld.11.0504. Epub 2012 Mar 8.

Reference Type DERIVED
PMID: 22410137 (View on PubMed)

Other Identifiers

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DOH-97-DC-1502

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

200707047M

Identifier Type: -

Identifier Source: org_study_id