TuberculosisNCT00889759
The Role of High Resolution-Computed Tomography (CT) in Tuberculosis (TB) Outbreak Investigation
An observational study of Tuberculosis, run by Armed Forces Capital Hospital, Republic of Korea.
Trial summary
The aim of this study is to evaluate the role of high-resolution computed tomography of the chest (HRCT) in the investigation of an outbreak of TB that developed in the South Korean army. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Apr 2009
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A military unit in South Korean Army
Who may be able to join
- All soldiers who assigned to the military battery where a tuberculosis outbreak occurred
Who cannot join
- Soldiers who could not complete study
About this study
Official title: The Role of Addition of High Resolution-CT in Outbreak Investigation of Tuberculosis
The aim of this study is to evaluate the role of high-resolution computed tomography of the chest (HRCT) in the investigation of an outbreak of TB that developed in the South Korean army.
Read the detailed description
Outbreak investigation including tuberculin skin test (TST), QuantiFERON® TB Gold In-Tube (QFT), and simple chest radiography (CXR) will be performed. For participants with any abnormal findings in these tests, HRCT will be carried out. Active pulmonary TB is diagnosed based on sputum studies or HRCT findings. In addition, participants with positive results both in TST and QTF will be treated as having a latent TB infection (LTBI). TST and QTF were repeated in participants with positive result in one of these tests. CXR will be repeated in all participants at 3 and 6 months of follow-up.
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Outbreaks
- Medical subject headings
- Tuberculosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startDec 2007
- Primary completionJan 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Capital Hospital, Republic of Korea
- Sponsor type
- Other government
- Investigators
- Jae-Joon Yim, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889759
- Sponsor's protocol ID
- TBoutbreak
- Status last verified
- Sep 2009
- First submitted
- 28 Apr 2009
- Last updated
- 23 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee SW, Jang YS, Park CM, Kang HY, Koh WJ, Yim JJ, Jeon K. The role of chest CT scanning in TB outbreak investigation. Chest. 2010 May;137(5):1057-64. doi: 10.1378/chest.09-1513. Epub 2009 Oct 31.
PubMed 19880906
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Addition of High Resolution-CT in Outbreak Investigation of Tuberculosis
- ClinicalTrials.gov ID
- NCT00889759
- Acronym / sponsor ID
- TBoutbreak
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Outbreaks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Armed Forces Capital Hospital, Republic of KoreaOther government
- Study start
- Dec 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 29 Apr 2009 (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 aim of this study is to evaluate the role of high-resolution computed tomography of the chest (HRCT) in the investigation of an outbreak of TB that developed in the South Korean army.
Detailed description
Outbreak investigation including tuberculin skin test (TST), QuantiFERON® TB Gold In-Tube (QFT), and simple chest radiography (CXR) will be performed. For participants with any abnormal findings in these tests, HRCT will be carried out. Active pulmonary TB is diagnosed based on sputum studies or HRCT findings. In addition, participants with positive results both in TST and QTF will be treated as having a latent TB infection (LTBI). TST and QTF were repeated in participants with positive result in one of these tests. CXR will be repeated in all participants at 3 and 6 months of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A military unit in South Korean Army
Key inclusion criteria (1 listed)
- All soldiers who assigned to the military battery where a tuberculosis outbreak occurred
Key exclusion criteria (1 listed)
- Soldiers who could not complete study
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
Not reported in the source record.
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 23 Sep 2009.
- Derived from this study: PubMed 19880906Lee SW, Jang YS, Park CM, Kang HY, Koh WJ, Yim JJ, Jeon K. The role of chest CT scanning in TB outbreak investigation. Chest. 2010 May;137(5):1057-64. doi: 10.1378/chest.09-1513. Epub 2009 Oct 31.
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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.
Jae-Joon Yim, MD principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Armed Forces Capital Hospital, Republic of 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 23 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00889759, which also lists 1 linked publication.
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 23 Sep 2009.