Latent TuberculosisNCT03010111
Latent Tuberculosis Infection in Korean Health Care Workers
A study testing QFT-IT Test and other blood sampling in people with Latent Tuberculosis, run by Hanyang University at 1 site in South Korea.
Trial summary
The investigators aim to study the prevalence of latent tuberculosis infection (LTBI) using whole-blood interferon-r release assays, and determine the risk factors of LTBI in Korean health care workers. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Latent Tuberculosis
- What is being tested?
- QFT-IT Test and other blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health care workers in University affiliated hospital
- Adult aged 20-65
Who cannot join
- Active tuberculosis
- Subjects diagnosed with HIV infection, malignancy
- Subjects having immunosuppressive drug therapy
Trial locations and contacts
1 site in 1 country.
Dong Won Park, M.D., Ph.D. contact
South Korea1 site, 1 recruiting
- Recruiting
Hanyang University Hospital
Seoul
Jang Won Shon, M.D., Ph.D., 82-2-2290-8351, jwsohn@hanyang.ac.kr
About this study
Official title: Latent Tuberculosis Infection in Korean Health Care Workers Using Interferon Gamma Releasing Assay
The investigators aim to study the prevalence of latent tuberculosis infection (LTBI) using whole-blood interferon-r release assays, and determine the risk factors of LTBI in Korean health care workers.
Read the detailed description
Further study details as provided by Hanyang University Hospital
- Conditions
- Latent Tuberculosis
- Being tested
- QFT-IT Test and other blood sampling
- Keywords
- Latent Tuberculosis, Interferons, Tuberculosis, Healthcare
- Medical subject headings
- Latent Tuberculosis, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QFT-IT Test and other blood samplingOther
In all enrolled health care workers, QFT-IT Test and other blood sampling were performed.
| Study group | Role | What they receive |
|---|---|---|
| health care workers | Other | health care workers including doctors, nurses, technicians and orderly who were hired in 2016 at the Hanyang University Hospital Receives: Other: QFT-IT Test and other blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of latent tuberculosis infection developed in Korean health care workers
The participants performed QuaniFERON-TB Gold In-Tube test (QFT-IT test) and blood sampling at enrollment. So, the length of time which from the start of the first test of very first participants to the end of test of very last participant is 3 months. The percentage of participants with LTBI in health care workers was evaluated.
Measured: Three months
Secondary outcomes (1)
Annual incidence of latent tuberculosis infection in Korean health care workers
QFT-IT test was performed at enrollment and repeated at point of one year after enrollment. So, the length of time which from the start of the first test of very first participants to the end of the second test of very last participant is 12 to 15 months. The percentage of participants with positive conversion in follow-up QFT-IT test (second test) was evaluated in participants who had negative results in the first QFT-IT test. Annual infection of LTBI was evaluated with the conversion of QFT-IT test through annual check up of QFT-IT test.
Measured: 1 year after first QFT-IT test (12-15 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent TuberculosisStudies of the same condition, open and under way.
- 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Won Park, Hanyang University
- Investigators
- Jang Won Shon, M.D., Ph.D., Principal investigator, Hanyang University Hospital, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010111
- Sponsor's protocol ID
- HYUMC_CM_001
- Status last verified
- Jan 2017
- First submitted
- 17 Dec 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latent Tuberculosis Infection in Korean Health Care Workers Using Interferon Gamma Releasing Assay
- ClinicalTrials.gov ID
- NCT03010111
- Acronym / sponsor ID
- HYUMC_CM_001
- Conditions
- Latent Tuberculosis
- Keywords
- Latent Tuberculosis, Interferons, Tuberculosis, Healthcare
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to study the prevalence of latent tuberculosis infection (LTBI) using whole-blood interferon-r release assays, and determine the risk factors of LTBI in Korean health care workers.
Detailed description
Further study details as provided by Hanyang University Hospital
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| health care workers | Other | Other: QFT-IT Test and other blood samplinghealth care workers including doctors, nurses, technicians and orderly who were hired in 2016 at the Hanyang University Hospital |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Health care workers in University affiliated hospital
- Adult aged 20-65
Key exclusion criteria (3 listed)
- Active tuberculosis
- Subjects diagnosed with HIV infection, malignancy
- Subjects having immunosuppressive drug therapy
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 |
|---|---|---|
| QFT-IT Test and other blood samplingIn all enrolled health care workers, QFT-IT Test and other blood sampling were performed. | Other | health care workers |
Primary outcome
Percentage of latent tuberculosis infection developed in Korean health care workers
Time frame: Three months
The participants performed QuaniFERON-TB Gold In-Tube test (QFT-IT test) and blood sampling at enrollment. So, the length of time which from the start of the first test of very first participants to the end of test of very last participant is 3 months. The percentage of participants with LTBI in health care workers was evaluated.
1 secondary outcome
Annual incidence of latent tuberculosis infection in Korean health care workers
Time frame: 1 year after first QFT-IT test (12-15 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Dong Won Park, M.D., Ph.D. contact
Jang Won Shon, M.D., Ph.D. principal investigator
Hanyang University Hospital, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QFT-IT Test and other blood sampling in people with Latent Tuberculosis, run by Hanyang University 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Jan 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Won Park, M.D., Ph.D. (portrayme@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of latent tuberculosis infection developed in Korean health care workers (time frame: Three months). 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 4 Jan 2017.