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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
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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
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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
Total Total of all reporting groups

Baseline Measures
    Isoniazid     Rifampin     Total  
Number of Participants  
[units: participants]
 		  184     180     364  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     183     180     363  
>=65 years     1     0     1  
Age  
[units: years]
Mean ± Standard Deviation 		  30.34  ± 9.59     31.51  ± 9.57     30.9  ± 9.59  
Gender  
[units: participants]
 		     
Female     11     14     25  
Male     173     166     339  
Region of Enrollment  
[units: participants]
 		     
United States     184     180     364  



  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 ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Number of Participants With Laboratory Test or Clinical Judgment Resulting in the Need to Stop Study Medication
Measure Description Liver function tests were taken at regular intervals and clinical symptoms were reviewed at regular intervals in both study groups. On the basis of these tests and examinations, physicians determined whether the study drug needed to be stopped.
Time Frame up to one year  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The number of participants was determined by power calculations using estimates of toxicity from the literature. The analysis was intention to treat.

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

Measured Values
    Isoniazid     Rifampin  
Number of Participants Analyzed  
[units: participants]
 		  184     180  
Number of Participants With Laboratory Test or Clinical Judgment Resulting in the Need to Stop Study Medication  
[units: participants]
 		  6     3  


Statistical Analysis 1 for Number of Participants With Laboratory Test or Clinical Judgment Resulting in the Need to Stop Study Medication
Groups [1] All groups
Method [2] Chi-squared
P Value [3] >.05
Risk Ratio (RR) [4] .51
95% Confidence Interval ( .13 to 2.01 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis was that there would be no difference in toxicity by study group, and a sample of 360 participants (180 in each group)was estimated to have sufficient power to detect a difference.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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
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  Other Adverse Events
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  More Information
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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