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

NCT00767975 | Completed Phase 3 DMC

• 2 other identifiers: 200707047MDOH-97-DC-1502
• Study Type: interventional
• Target: 2,384
• Locations: 1 country
• Sites: 1

Brief Summary

LTBI Treatment is effective in prison

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• COMPLETE RATE OF LTBI TREATMENT

  1.5 year

Secondary Outcomes (1)

• Efficacy

  3 year

Study Arms (2)

2

NO INTERVENTION

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.

1

EXPERIMENTAL

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

Drug: isoniazid , randomized, open label; Drug: rifampin, randomized, open label

Interventions

isoniazid , randomized, open label DRUG

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

1

rifampin, randomized, open label DRUG

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

1

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• all people who is LTBI, and have ability to sign the informed concent

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Taipei Prison

Taoyuan District, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 22410137 DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Isoniazid; Random Allocation; Rifampin

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Li-Min Huang, MD, PHD

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: October 7, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 29, 2010

Record last verified: 2010-11

Locations

TW (1)