TuberculosisNCT01850043
The Epidemiology of TST Change in Korea
An observational study of Tuberculosis and Latent Tuberculosis, run by Asan Medical Center at 1 site in South Korea.
Trial summary
TST will be analyzed in young general population in Korea. Young adults undertake TST as CDC recommendation. Participants with chest radiograph showing active TB lesion are excluded from this study. Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Latent Tuberculosis
- How many people
- 5,552 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2005to May 2012
- Phase
- Observational
- 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 18 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: A term of whole military conscripts per year
Who may be able to join
- Military Conscripts age 18-29 years old
Who cannot join
- Chest X-ray suggests active TB
- Positive HIV in serology
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Korean Institute of Tuberculosis
Osong, North Chungcheong, 396-954
About this study
Official title: The Trend of Tuberculin Skin Test in Korea
TST will be analyzed in young general population in Korea. Young adults undertake TST as CDC recommendation. Participants with chest radiograph showing active TB lesion are excluded from this study.
Read the detailed description
Enroll criteria
- A term of whole military conscripts per year in one Reserve Force Battalion
- Military conscripts gather from all around area in Korea randomly
- Each participant undertake a chest X-ray (CXR) and blood tests including human immunodeficiency virus (HIV) at the start of initiatory training.
Exclusion Criteria
- Chest X-ray suggesting active TB
- HIV positive in serology
Design
- After giving informed consent, all participants receive one-step TST following standard procedures.
- The largest transverse diameter of induration is measured 48-72hr after injection.
- The investigator and these trained nurses were blinded to the status of their demographic characteristics.
- Conditions
- Tuberculosis, Latent Tuberculosis
- Medical subject headings
- Tuberculosis, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Military Conscripts | A term of whole military conscripts per year in one Reserve Force Battalion. Military conscripts gather from all around area in Korea randomly |
What is being measured
The primary outcome is the main question the study is designed to answer.
TST positivity TST rate
Investigators measure induration size of tuberculin skin test 48 after tuberculin injection.
Measured: Two days after tuberculin injection
Secondary outcomes (1)
BCG scar rates
Measured: The day of tuberculin injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startMay 2005
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Asan 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 5,552 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sei Won Lee, Asan Medical Center
- Investigators
- HeeJin Kim, MD, Principal investigator, The Korean Institute of Tuberculosis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850043
- Sponsor's protocol ID
- KoreanTSTtrends
- Status last verified
- Dec 2013
- First submitted
- 2 May 2013
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Trend of Tuberculin Skin Test in Korea
- ClinicalTrials.gov ID
- NCT01850043
- Acronym / sponsor ID
- KoreanTSTtrends
- Conditions
- Tuberculosis, Latent Tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,552 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 9 May 2013 (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.
TST will be analyzed in young general population in Korea. Young adults undertake TST as CDC recommendation. Participants with chest radiograph showing active TB lesion are excluded from this study.
Detailed description
Enroll criteria
- A term of whole military conscripts per year in one Reserve Force Battalion
- Military conscripts gather from all around area in Korea randomly
- Each participant undertake a chest X-ray (CXR) and blood tests including human immunodeficiency virus (HIV) at the start of initiatory training.
Exclusion Criteria
- Chest X-ray suggesting active TB
- HIV positive in serology
Design
- After giving informed consent, all participants receive one-step TST following standard procedures.
- The largest transverse diameter of induration is measured 48-72hr after injection.
- The investigator and these trained nurses were blinded to the status of their demographic characteristics.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Military Conscripts | – | –A term of whole military conscripts per year in one Reserve Force Battalion. Military conscripts gather from all around area in Korea randomly |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A term of whole military conscripts per year
Key inclusion criteria (1 listed)
- Military Conscripts age 18-29 years old
Key exclusion criteria (2 listed)
- Chest X-ray suggests active TB
- Positive HIV in serology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TST positivity TST rate
Time frame: Two days after tuberculin injection
Investigators measure induration size of tuberculin skin test 48 after tuberculin injection.
1 secondary outcome
BCG scar rates
Time frame: The day of tuberculin injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
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.
HeeJin Kim, MD principal investigator
The Korean Institute of Tuberculosis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Latent Tuberculosis, run by Asan 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 2 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 12 Dec 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
TST positivity TST rate (time frame: Two days after tuberculin injection). 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 12 Dec 2013.