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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01007396
• Collaborator: (none)
• Enrollment: 322
• Location: 1
• Arm: 1
• Duration (Months): 23
• Patients Per Site Per Month: 14

Study Details

Study Description

Brief Summary

The present study was to evaluate the usefulness of a whole-blood interferon-r release assays (IGRAs) as diagnostic tool of the latent tuberculosis infection for healthcare workers.

Condition or Disease	Intervention/Treatment	Phase
Latent Tuberculosis Infection	Other: 1-step tuberculin skin test (TST) and blood sampling	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 322 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: new healthcare workers doctors and nurses who were newly hired in 2008 at the Samsung Medical Center	Other: 1-step tuberculin skin test (TST) and blood sampling; In only new healthcare workers, the 1-step TST and quantiFERON-TB Gold In-Tube test were performed.

Outcome Measures

Primary Outcome Measures

1. Annual Incidence of Tuberculosis Infection Among Newly Employed Doctors and Nurses in Korea [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.]

   The participants performed QuaniFERON-TB Gold In-Tube test (QFT-IT test). Annual infection of tuberculosis infection was evaluated with the conversion of QFT-IT test through annual check up of QFT-IT test. The definitions for QFT-IT test conversion was based on the CDC definition (Baseline IFN-r < 0.35 IU/ml and follow-up IFN-r ≥ 0.35 IU/ml).

Secondary Outcome Measures

1. Negative Conversion Rate in Follow-up QuantiFERON-TB Gold In-Tube Test (QFT-IT Test) After Treatment of Latent Tuberculosis Infection (LTBI) [3 months after LTBI treatment]

   The percentage of participants with negative conversion in follow-up QFT-IT test after LTBI treatment, out of those who had QFT-IT test conversion after one year of employment and agreed to undergo treatment for LTBI according to our recommendation Participants with QFT-IT test conversion were recommended for LTBI therapy using 3 months of daily isoniazid and rifampicin, which was the regular treatment for LTBI in our institution. The QFT-IT test was repeated after LTBI therapy. Negative conversion was defined as baseline IFN-r ≥ 0.35 and follow-up IFN-r < 0.35 IU/ml.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• doctors and nurses newly hired at Samsung Medical Center between February, 2008 and November, 2008.

Exclusion Criteria:

• Non-applicable

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	135-710

Sponsors and Collaborators

• Samsung Medical Center

Investigators

• Principal Investigator: Won-Jung Koh, M.D., Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Won-Jung Koh, MD, PhD, Associated professor, school of medicine, sungkyunkwan university, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT01007396
• Other Study ID Numbers: 2007-09-019
• First Posted: Nov 4, 2009
• Last Update Posted: Jan 11, 2012
• Last Verified: Dec 1, 2011

• Keywords provided by Won-Jung Koh, MD, PhD, Associated professor, school of medicine, sungkyunkwan university, Samsung Medical Center: Interferon-gamma release assay
• Additional relevant MeSH terms: Infections; Communicable Diseases; Tuberculosis; Latent Tuberculosis

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	New Healthcare Workers
Arm/Group Description	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.
Period Title: Overall Study
STARTED	322
COMPLETED	275
NOT COMPLETED	47

Baseline Characteristics

Arm/Group Title	New Healthcare Workers
Arm/Group Description	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.
Overall Participants	322
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	24
Sex: Female, Male (Count of Participants)
Female	274 85.1%
Male	48 14.9%
Region of Enrollment (participants) [Number]
Korea, Republic of	322 100%

Outcome Measures

1. Primary Outcome

Title	Annual Incidence of Tuberculosis Infection Among Newly Employed Doctors and Nurses in Korea
Description	The participants performed QuaniFERON-TB Gold In-Tube test (QFT-IT test). Annual infection of tuberculosis infection was evaluated with the conversion of QFT-IT test through annual check up of QFT-IT test. The definitions for QFT-IT test conversion was based on the CDC definition (Baseline IFN-r < 0.35 IU/ml and follow-up IFN-r ≥ 0.35 IU/ml).
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.

Outcome Measure Data

Analysis Population Description

Of the 322 healthcare workers (HCWs), 275 (85%) underwent repeat QuantiFERON-TB Gold In-Tube test (QFT-IT test) after 1 year of employment; the 47 participants who had resigned were excluded. Two participants with indeterminate results on the baseline QFT-IT test were excluded from the analysis.

Arm/Group Title	New Healthcare Workers
Arm/Group Description	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.
Measure Participants	273
Number [number of new cases per 1000 person/year]	57

2. Secondary Outcome

Title	Negative Conversion Rate in Follow-up QuantiFERON-TB Gold In-Tube Test (QFT-IT Test) After Treatment of Latent Tuberculosis Infection (LTBI)
Description	The percentage of participants with negative conversion in follow-up QFT-IT test after LTBI treatment, out of those who had QFT-IT test conversion after one year of employment and agreed to undergo treatment for LTBI according to our recommendation Participants with QFT-IT test conversion were recommended for LTBI therapy using 3 months of daily isoniazid and rifampicin, which was the regular treatment for LTBI in our institution. The QFT-IT test was repeated after LTBI therapy. Negative conversion was defined as baseline IFN-r ≥ 0.35 and follow-up IFN-r < 0.35 IU/ml.
Time Frame	3 months after LTBI treatment

Outcome Measure Data

Analysis Population Description

Thirteen participants agreed to undergo treatment for latent tuberculosis infection and completed 3 months therapy.

Arm/Group Title	New Healthcare Workers
Arm/Group Description	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.
Measure Participants	13
Number [Percentage of participants]	15 4.7%

Adverse Events

Adverse Event Reporting Description	Serious and/or other [non-serious] adverse events were not collected/assessed.
Arm/Group Title	New Healthcare Workers
Arm/Group Description	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.
All Cause Mortality
	New Healthcare Workers
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	New Healthcare Workers
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	New Healthcare Workers
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.