LTBI_prison: Active Screening of Latent TB Infection, Treatment and Long Term Follow-up in Prison
Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00767975
Collaborator
(none)
2,384
1
2
34
70.1
Study Details
Study Description
Brief Summary
LTBI Treatment is effective in prison
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
LTBI treatment will be conducted in a prison with either isoniazid or rifampin
Study Design
Study Type:
Interventional
Actual Enrollment
:
2384 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Active Screening of Latent TB Infection, Treatment and Long Term Follow-up in Prison
Study Start Date
:
Jan 1, 2008
Actual Primary Completion Date
:
Nov 1, 2010
Actual Study Completion Date
:
Nov 1, 2010
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures
- COMPLETE RATE OF LTBI TREATMENT [1.5 year]
Secondary Outcome Measures
- Efficacy [3 year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Taipei Prison | Taoyuan | Taiwan |
Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
- Principal Investigator: Li-Min Huang, MD, PHD, National University Hospital, Singapore
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00767975
Other Study ID Numbers:
- 200707047M
- DOH-97-DC-1502
First Posted:
Oct 7, 2008
Last Update Posted:
Nov 29, 2010
Last Verified:
Nov 1, 2010