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

Primary Purpose

Tuberculosis

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
isoniazid , randomized, open label
rifampin, randomized, open label
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tuberculosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Taipei Prison

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

2

1

Arm 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.

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

Outcomes

Primary Outcome Measures

COMPLETE RATE OF LTBI TREATMENT

Secondary Outcome Measures

Efficacy

Full Information

First Posted
January 10, 2008
Last Updated
November 25, 2010
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00767975
Brief Title
Active Screening of Latent TB Infection, Treatment and Long Term Follow-up in Prison
Acronym
LTBI_prison
Official Title
Active Screening of Latent TB Infection, Treatment and Long Term Follow-up in Prison
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
LTBI Treatment is effective in prison
Detailed Description
LTBI treatment will be conducted in a prison with either isoniazid or rifampin

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2384 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
No Intervention
Arm 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.
Arm Title
1
Arm Type
Experimental
Arm Description
Provided INH 6m or RMP 4 m; whether enter treatment arm is determined by patient's willingness
Intervention Type
Drug
Intervention Name(s)
isoniazid , randomized, open label
Intervention Description
isoniazid 300mg/tab 1 tab qd, 6 months (the other treatment arm is rifampin)
Intervention Type
Drug
Intervention Name(s)
rifampin, randomized, open label
Intervention Description
rifampin 300mg/capsule 2 caps qd, 4 months (the other treatment arm is isoniazid)
Primary Outcome Measure Information:
Title
COMPLETE RATE OF LTBI TREATMENT
Time Frame
1.5 year
Secondary Outcome Measure Information:
Title
Efficacy
Time Frame
3 year

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Min Huang, MD, PHD
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Prison
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22410137
Citation
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.
Results Reference
derived

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

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