Trial Outcomes & Findings for Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay (NCT NCT01007396)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

322 participants

Primary outcome timeframe

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.

Results posted on

2012-01-11

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	322
Overall Study COMPLETED	275
Overall Study NOT COMPLETED	47

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	47

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	New Healthcare Workers n=322 Participants 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.
Age Continuous	24 years n=5 Participants
Sex: Female, Male Female	274 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants
Region of Enrollment Korea, Republic of	322 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Population: 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.

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).

Outcome measures

Outcome measures
Measure	New Healthcare Workers n=273 Participants 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.
Annual Incidence of Tuberculosis Infection Among Newly Employed Doctors and Nurses in Korea	57 number of new cases per 1000 person/year

SECONDARY outcome

Timeframe: 3 months after LTBI treatment

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

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.

Outcome measures

Outcome measures
Measure	New Healthcare Workers n=13 Participants 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.
Negative Conversion Rate in Follow-up QuantiFERON-TB Gold In-Tube Test (QFT-IT Test) After Treatment of Latent Tuberculosis Infection (LTBI)	15 Percentage of participants

Adverse Events

New Healthcare Workers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Won-Jung Koh

Samsung Medical Center

Phone: 82-2-3410-3429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place