TuberculosisNCT01038830
QuantiFERON Change During Anti-tuberculosis Medication
An observational study of Tuberculosis and Interferon-gamma Release Assay, run by Armed Forces Capital Hospital, Republic of Korea at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate the change of QuantiFERON-TB gold in tube assay (QFT) during the treatment of active tuberculosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis, Interferon-gamma Release Assay
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2008to May 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Young healthy subjects in Korean military
Who may be able to join
- All subjects with active tuberculosis
Who cannot join
- Subjects who cannot complete study
- Subjects who have taken anti-tuberculosis medication for more than a month before visit of our hospital
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Armed Forces Capital Hospital
Seongnam-si, Gyeonggi-do, 463-040
About this study
Official title: The Change in Level of Interferon-gamma Assay in Active Tuberculosis Patients During Treatment
The aim of this study is to evaluate the change of QuantiFERON-TB gold in tube assay (QFT) during the treatment of active tuberculosis.
Read the detailed description
Patients with active pulmonary tuberculosis are enrolled and, QFTs are performed for each subjects before treatment and 1, 3, 6 months after treatment. Investigators check the level of interferon-gamma, and reversion and conversion of this test.
- Conditions
- Tuberculosis, Interferon-gamma Release Assay
- 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 posted24 Dec 2009 (estimated)
- Study startMay 2008
- Primary completionApr 2010
- Study completionMay 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Capital Hospital, Republic of Korea
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038830
- Sponsor's protocol ID
- QFTchange
- Status last verified
- Dec 2009
- First submitted
- 23 Dec 2009
- Last updated
- 14 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Change in Level of Interferon-gamma Assay in Active Tuberculosis Patients During Treatment
- ClinicalTrials.gov ID
- NCT01038830
- Acronym / sponsor ID
- QFTchange
- Conditions
- Tuberculosis, Interferon-gamma Release Assay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Armed Forces Capital Hospital, Republic of KoreaOther government
- Study start
- May 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 24 Dec 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 change of QuantiFERON-TB gold in tube assay (QFT) during the treatment of active tuberculosis.
Detailed description
Patients with active pulmonary tuberculosis are enrolled and, QFTs are performed for each subjects before treatment and 1, 3, 6 months after treatment. Investigators check the level of interferon-gamma, and reversion and conversion of this test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Young healthy subjects in Korean military
Key inclusion criteria (1 listed)
- All subjects with active tuberculosis
Key exclusion criteria (2 listed)
- Subjects who cannot complete study
- Subjects who have taken anti-tuberculosis medication for more than a month before visit of our hospital
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 14 Jun 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.
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 and Interferon-gamma Release Assay, run by Armed Forces Capital Hospital, Republic of Korea 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 14 Jun 2010. 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.
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 14 Jun 2010.