TuberculosisNCT00981071
The Time of Positive Conversion of Interferon-γ Releasing Assay After Tuberculosis Exposure
An observational study of Tuberculosis, run by Armed Forces Capital Hospital, Republic of Korea.
Trial summary
The aim is to evaluate the time of positive conversion after exposure to smear positive pulmonary tuberculosis (TB) in a platoon of Korean military, a closed communal setting. 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
- 32 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Apr 2010
- 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 platoon where a tuberculosis outbreak occurred
Who cannot join
- Soldiers who could not complete study or refused the study protocol
About this study
The aim is to evaluate the time of positive conversion after exposure to smear positive pulmonary tuberculosis (TB) in a platoon of Korean military, a closed communal setting.
Read the detailed description
In a platoon where TB outbreak occurred, we performed low dose chest CT (LDCT), QuantiFERON-TB gold in tube (QFT) and two-step (0, 4weeks) TST for outbreak investigation. We perform QFT at 0, 2, 4, 8 and 12 weeks after initial investigation for soldiers with negative QFT results, and soldiers with positive QFT and normal LDCT took isoniazid and rifampin for 3 months as treatment of latent TB.
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, QuantiFERON, Outbreak, Conversion
- 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 |
|---|---|---|
| A platoon with TB outbreak | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2010
- Study completionApr 2010
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.
- 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
- 32 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
- NCT00981071
- Sponsor's protocol ID
- QFTconversion
- Status last verified
- Apr 2010
- First submitted
- 21 Sep 2009
- Last updated
- 8 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Time of Positive Conversion of Interferon-γ Releasing Assay After Tuberculosis Exposure
- ClinicalTrials.gov ID
- NCT00981071
- Acronym / sponsor ID
- QFTconversion
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, QuantiFERON, Outbreak, Conversion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Armed Forces Capital Hospital, Republic of KoreaOther government
- Study start
- May 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 22 Sep 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 is to evaluate the time of positive conversion after exposure to smear positive pulmonary tuberculosis (TB) in a platoon of Korean military, a closed communal setting.
Detailed description
In a platoon where TB outbreak occurred, we performed low dose chest CT (LDCT), QuantiFERON-TB gold in tube (QFT) and two-step (0, 4weeks) TST for outbreak investigation. We perform QFT at 0, 2, 4, 8 and 12 weeks after initial investigation for soldiers with negative QFT results, and soldiers with positive QFT and normal LDCT took isoniazid and rifampin for 3 months as treatment of latent TB.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A platoon with TB outbreak | – | – |
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 platoon where a tuberculosis outbreak occurred
Key exclusion criteria (1 listed)
- Soldiers who could not complete study or refused the study protocol
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 8 Apr 2010.
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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 8 Apr 2010. 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?
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 8 Apr 2010.