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

November 25, 2010 updated by: National Taiwan University Hospital
LTBI Treatment is effective in prison

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

2384

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan
        • Taipei Prison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 1
Provided INH 6m or RMP 4 m; whether enter treatment arm is determined by patient's willingness
Drug: isoniazid , randomized, open label
isoniazid 300mg/tab 1 tab qd, 6 months (the other treatment arm is rifampin)
Drug: rifampin, randomized, open label
rifampin 300mg/capsule 2 caps qd, 4 months (the other treatment arm is isoniazid)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
COMPLETE RATE OF LTBI TREATMENT
Time Frame: 1.5 year
1.5 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy
Time Frame: 3 year
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Li-Min Huang, MD, PHD, National University Hospital, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

October 6, 2008

First Posted (Estimate)

October 7, 2008

Study Record Updates

Last Update Posted (Estimate)

November 29, 2010

Last Update Submitted That Met QC Criteria

November 25, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200707047M
  • DOH-97-DC-1502 (Other Grant/Funding Number: Taiwan CDC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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