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

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

This study is currently recruiting participants.

Verified by National Taiwan University Hospital, October 2008

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00767975

Purpose

LTBI Treatment is effective in prison

Condition	Intervention	Phase
Tuberculosis	Drug: isoniazid or rifampin	Phase III

MedlinePlus related topics: Tuberculosis

Drug Information available for: Isoniazid Rifampin Ftivazide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Active Screening of Latent TB Infection, Treatment and Long Term Follow-up in Prison

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

COMPLETE RATE OF LTBI TREATMENT [ Time Frame: 1.5 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficacy [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	3500
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Use isoniazid or rifampin as intervention	Drug: isoniazid or rifampin isoniazid 300mg/tab 1 tab qd, 6 months or rifampin 300mg/capsule 2 caps qd, 4 months
2: No Intervention	Drug: isoniazid or rifampin isoniazid 300mg/tab 1 tab qd, 6 months or rifampin 300mg/capsule 2 caps qd, 4 months

Detailed Description:

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

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767975

Contacts

Contact: Li-Min Huang, MD, PHD

+886-2-23123456 ext 5138

lmhuang@ntu.edu.tw

Locations

Taiwan
Taipei Prison	Recruiting
Taoyuan, Taiwan
Principal Investigator: Li-Min Huang, MD.PHD.

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator:

Li-Min Huang, MD, PHD

National University Hospital, Singapore

More Information

Responsible Party:	National Taiwan University Hospital ( Haung Li-Min )
Study ID Numbers:	200707047M, DOH-97-DC-1502
Study First Received:	January 10, 2008
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00767975
Health Authority:	Taiwan: Department of Health

Study placed in the following topic categories:

Bacterial Infections
Rifampin
Gram-Positive Bacterial Infections

Mycobacterium Infections
Tuberculosis
Isoniazid

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Actinomycetales Infections
Pharmacologic Actions

Antibiotics, Antitubercular
Anti-Bacterial Agents
Therapeutic Uses
Antitubercular Agents
Nucleic Acid Synthesis Inhibitors
Fatty Acid Synthesis Inhibitors
Leprostatic Agents

ClinicalTrials.gov processed this record on January 16, 2009