TuberculosisNCT01376843
Conversion Rate of (TST) Tuberculin Skin Test and Quantiferon-TB Gold In Tube Assay in Health Care Workers
An observational study of Tuberculosis, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to access conversion rate of TST (Tuberculin skin test) and Quantiferon-TB Gold In tube assay in health care workers. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Tuberculosis
- How many people
- 53 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: health care workers who performed TST or Quantiferon-TB Gold In tube assay before
Who may be able to join
- age 20-75, men and women
- participant who was enrolled in the study of latent tuberculosis in health care worker (IRB No.4-2009-0187)
- high risk or low risk health care worker who was performed TST or Quantiferon-TB Gold In tube assay before
Who cannot join
- age < 20
- person who don't agree with enrollment
- illiterate
- person who is diagnosed as active tuberculosis now
- person who has history of hypersensitivity on PPD (tuberculin purified protein derivative)
- pregnant woman
- person who is treated as active tuberculosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conversion Rate of TST and Quantiferon-TB Gold In Tube Assay in Health Care Workers
The purpose of this study is to access conversion rate of TST (Tuberculin skin test) and Quantiferon-TB Gold In tube assay in health care workers.
- Conditions
- Tuberculosis
- Keywords
- latent tuberculosis in health care workers
- Medical subject headings
- 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 |
|---|---|---|
| Health care workers | health care workers who performed TST or Quantiferon-TB Gold In tube assay before |
What is being measured
The primary outcome is the main question the study is designed to answer.
conversion rate of latent tuberculosis infection in hospital workers
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376843
- Sponsor's protocol ID
- 4-2011-0161
- Status last verified
- Mar 2013
- First submitted
- 16 Jun 2011
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Menzies D, Fanning A, Yuan L, Fitzgerald M. Tuberculosis among health care workers. N Engl J Med. 1995 Jan 12;332(2):92-8. doi: 10.1056/NEJM199501123320206. No abstract available.
PubMed 7990907Jiamjarasrangsi W, Hirunsuthikul N, Kamolratanakul P. Tuberculosis among health care workers at King Chulalongkorn Memorial Hospital, 1988-2002. Int J Tuberc Lung Dis. 2005 Nov;9(11):1253-8.
PubMed 16333934Schwartzman K, Loo V, Pasztor J, Menzies D. Tuberculosis infection among health care workers in Montreal. Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):1006-12. doi: 10.1164/ajrccm.154.4.8887599.
PubMed 8887599Kruuner A, Danilovitsh M, Pehme L, Laisaar T, Hoffner SE, Katila ML. Tuberculosis as an occupational hazard for health care workers in Estonia. Int J Tuberc Lung Dis. 2001 Feb;5(2):170-6.
PubMed 11258511
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion Rate of TST and Quantiferon-TB Gold In Tube Assay in Health Care Workers
- ClinicalTrials.gov ID
- NCT01376843
- Acronym / sponsor ID
- 4-2011-0161
- Conditions
- Tuberculosis
- Keywords
- latent tuberculosis in health care workers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 20 Jun 2011 (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 purpose of this study is to access conversion rate of TST (Tuberculin skin test) and Quantiferon-TB Gold In tube assay in health care workers.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health care workers | – | –health care workers who performed TST or Quantiferon-TB Gold In tube assay before |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- health care workers who performed TST or Quantiferon-TB Gold In tube assay before
Key inclusion criteria (3 listed)
- age 20-75, men and women
- participant who was enrolled in the study of latent tuberculosis in health care worker (IRB No.4-2009-0187)
- high risk or low risk health care worker who was performed TST or Quantiferon-TB Gold In tube assay before
Key exclusion criteria (7 listed)
- age < 20
- person who don't agree with enrollment
- illiterate
- person who is diagnosed as active tuberculosis now
- person who has history of hypersensitivity on PPD (tuberculin purified protein derivative)
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
conversion rate of latent tuberculosis infection in hospital workers
Time frame: 3months
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 6 Mar 2013.
- Background: PubMed 7990907Menzies D, Fanning A, Yuan L, Fitzgerald M. Tuberculosis among health care workers. N Engl J Med. 1995 Jan 12;332(2):92-8. doi: 10.1056/NEJM199501123320206. No abstract available.
- Background: PubMed 16333934Jiamjarasrangsi W, Hirunsuthikul N, Kamolratanakul P. Tuberculosis among health care workers at King Chulalongkorn Memorial Hospital, 1988-2002. Int J Tuberc Lung Dis. 2005 Nov;9(11):1253-8.
- Background: PubMed 8887599Schwartzman K, Loo V, Pasztor J, Menzies D. Tuberculosis infection among health care workers in Montreal. Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):1006-12. doi: 10.1164/ajrccm.154.4.8887599.
- Background: PubMed 11258511Kruuner A, Danilovitsh M, Pehme L, Laisaar T, Hoffner SE, Katila ML. Tuberculosis as an occupational hazard for health care workers in Estonia. Int J Tuberc Lung Dis. 2001 Feb;5(2):170-6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Yonsei 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 3 inclusion and 7 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 6 Mar 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?
conversion rate of latent tuberculosis infection in hospital workers (time frame: 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01376843, which also lists 4 linked publications.
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 6 Mar 2013.