Text Size

Treatment of Latent TB Infection for Jailed Persons

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00128206
First received: August 5, 2005
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
Results First Received: September 21, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tuberculosis
Interventions: Drug: Isoniazid
Drug: Rifampin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Inmates in the San Francisco City and County Jail diagnosed with latent tuberculosis infection (LTBI) at jail entry were recruited,consented and enrolled between 11/30/2004 and 9/24/2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 416 inmates with LTBI who consented to be enrolled, 52 were not randomized because of abnormal liver function tests (20), they were released before they could be assigned to a group (30), or they subsequently changed their mind and refused participation (2).

Reporting Groups
  Description
Isoniazid isoniazid (INH) (900 mg orally) given twice weekly for 9 months
Rifampin rifampin (600 mg orally) given daily for 4 months

Participant Flow:   Overall Study
    Isoniazid     Rifampin  
STARTED     184     180  
COMPLETED     47     60  
NOT COMPLETED     137     120  
Lost to Follow-up                 137                 118  
Adverse Event                 0                 2  



  Baseline Characteristics
  Show Baseline Characteristics


  Outcome Measures

1.  Primary:   Number of Participants With Laboratory Test or Clinical Judgment Resulting in the Need to Stop Study Medication   [ Time Frame: up to one year ]
  Show Outcome Measure 1

2.  Secondary:   Completion of Therapy   [ Time Frame: course of treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Cost Effectiveness   [ Time Frame: course of treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Initial enrollment estimates were not met, from lower TB rates, increased deportation rates and fewer Jail personnel for LTBI testing. The complexity of treatment in the jail led to technical problems in the analytic plan.  


Results Point of Contact:  
Name/Title: Mary White
Organization: University of California, San Francisco
phone: 415-476-5213
e-mail: mary.white@nursing.ucsf.edu


No publications provided by University of California, San Francisco

Publications automatically indexed to this study:


Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00128206     History of Changes
Other Study ID Numbers: 03-135, U01AI051315
Study First Received: August 5, 2005
Results First Received: September 21, 2010
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board