Latent Tuberculosis InfectionNCT01007396
Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay
A study testing 1-step tuberculin skin test (TST) and blood sampling in people with Latent Tuberculosis Infection, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Latent Tuberculosis Infection
- What is being tested?
- 1-step tuberculin skin test (TST) and blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- doctors and nurses newly hired at Samsung Medical Center between February, 2008 and November, 2008.
Who cannot join
- Non-applicable
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Latent Tuberculosis Infection
- Being tested
- 1-step tuberculin skin test (TST) and blood sampling
- Keywords
- Interferon-gamma release assay
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-step tuberculin skin test (TST) and blood samplingOther
In only new healthcare workers, the 1-step TST and quantiFERON-TB Gold In-Tube test were performed.
| Study group | Role | What they receive |
|---|---|---|
| new healthcare workers | Other | doctors and nurses who were newly hired in 2008 at the Samsung Medical Center Receives: Other: 1-step tuberculin skin test (TST) and blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual Incidence of Tuberculosis Infection Among Newly Employed Doctors and Nurses in Korea
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).
Measured: 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.
Secondary outcomes (1)
Negative Conversion Rate in Follow-up QuantiFERON-TB Gold In-Tube Test (QFT-IT Test) After Treatment of Latent Tuberculosis Infection (LTBI)
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.
Measured: 3 months after LTBI treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Latent Tuberculosis InfectionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won-Jung Koh, Samsung Medical Center
- Investigators
- Won-Jung Koh, M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007396
- Sponsor's protocol ID
- 2007-09-019
- Status last verified
- Dec 2011
- First submitted
- 2 Nov 2009
- Last updated
- 11 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay
- ClinicalTrials.gov ID
- NCT01007396
- Acronym / sponsor ID
- 2007-09-019
- Conditions
- Latent Tuberculosis Infection
- Keywords
- Interferon-gamma release assay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Nov 2009 (estimated)
- Results
- Posted 11 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| new healthcare workers | Other | Other: 1-step tuberculin skin test (TST) and blood samplingdoctors and nurses who were newly hired in 2008 at the Samsung Medical Center |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- doctors and nurses newly hired at Samsung Medical Center between February, 2008 and November, 2008.
Key exclusion criteria (1 listed)
- Non-applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-step tuberculin skin test (TST) and blood samplingIn only new healthcare workers, the 1-step TST and quantiFERON-TB Gold In-Tube test were performed. | Other | new healthcare workers |
Primary outcome
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.
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).
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won-Jung Koh, M.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-step tuberculin skin test (TST) and blood sampling in people with Latent Tuberculosis Infection, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2012.