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Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Won-Jung Koh, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01007396
First received: November 2, 2009
Last updated: December 6, 2011
Last verified: December 2011
History of Changes
Results First Received: May 17, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Screening
Condition: Latent Tuberculosis Infection
Intervention: Other: 1-step tuberculin skin test (TST) and blood sampling

  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
The study participants were doctors and nurses who were newly hired in 2008 at the Samsung Medical Center, a 2,000-bed referral hospital in Seoul, Korea.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
New Healthcare Workers

a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.

After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital.

Participant Flow:   Overall Study
    New Healthcare Workers  
STARTED     322  
COMPLETED     275  
NOT COMPLETED     47  
Lost to Follow-up                 47  



  Baseline Characteristics
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Reporting Groups
  Description
New Healthcare Workers

a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.

After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital.

Baseline Measures
    New Healthcare Workers  
Number of Participants  
[units: participants]
 		  322  
Age  
[units: years]
Median ( Inter-Quartile Range ) 		  24  
  ( 22 to 25 )  
Gender  
[units: participants]
 		 
Female     274  
Male     48  
Region of Enrollment  
[units: participants]
 		 
Korea, Republic of     322  



  Outcome Measures
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1.  Primary:   Annual Incidence of Tuberculosis Infection Among Newly Employed Doctors and Nurses in Korea   [ Time Frame: QFT-IT test was performed at enrollment and repeated at point of one year after enrollment. So, the length of timw which from the start of the first test of very first participant to the end of second test of very last participant is 2 years. ]
  Show Outcome Measure 1

2.  Secondary:   Negative Conversion Rate in Follow-up QuantiFERON-TB Gold In-Tube Test (QFT-IT Test) After Treatment of Latent Tuberculosis Infection (LTBI)   [ Time Frame: 3 months after LTBI treatment ]
  Show Outcome Measure 2


  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
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Results Point of Contact:  
Name/Title: Won-Jung Koh
Organization: Samsung Medical Center
phone: 82-2-3410-3429
e-mail: wjkoh@skku.edu


No publications provided


Responsible Party: Won-Jung Koh, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01007396     History of Changes
Other Study ID Numbers: 2007-09-019
Study First Received: November 2, 2009
Results First Received: May 17, 2010
Last Updated: December 6, 2011
Health Authority: South Korea: Institutional Review Board