TuberculosisPhase 4NCT00311220
Use TST and QFT-RD1 Test to Monitor the Tuberculous Infection in Patients, Close Contact People and Health Care Workers
A Phase 4 study testing tuberculin for skin test in people with Tuberculosis and Latent Tuberculosis, run by Taichung Veterans General Hospital at 1 site in China.
Trial summary
Tuberculosis is still the most common infectious disease in Taiwan. The infants in Taiwan have been vaccinated at birth with BCG -Tokyo 171 strain since 1951. The BCG vaccination rate is 97% among first grade students in a recent national survey. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Latent Tuberculosis, Tuberculosis Contact
- What is being tested?
- tuberculin for skin test
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jan 2004to Nov 2006
- Phase
- Phase 4
- 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 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- people close contact with active tuberculosis patients including health care workers, people in the veterans home, and/or the close contact family or high risk area or county
- low risk volunteers : the clerk and interns doctors initially in the hospital training
Who cannot join
- HIV
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital
Taichung, Taiwan, 407
Shen Gwan Han, MD, +886-4-23592525 ext. 3217, 911B@vghtc.gov.tw
Shen Gwan Han, MD
About this study
Official title: Phase IV Study of the Quantiferon-RD1 Test
Tuberculosis is still the most common infectious disease in Taiwan. The infants in Taiwan have been vaccinated at birth with BCG -Tokyo 171 strain since 1951. The BCG vaccination rate is 97% among first grade students in a recent national survey. Even with such a high BCG vaccination coverage, Taiwan still has a relatively high TB incidence rate. In 2004, there were totally 16,784 newly diagnosed TB cases and the annual incidence was 74.11 per 100,000 population nationally. Nearly 70% of the incidence cases were men and 30.4% were women. The mean age of incidence cases was 57.8 years old (median=63). 8,440(50.29%) patients were elderly than 65 years old. The elderly men did not receive the BCG vaccination and were the most important group to develop newly diagnosed tuberculosis and a special issue for the national TB control program in Taiwan.
The tuberculin skin test (TST) is the only widely available method for detecting whether people have an immunologic reactivity to mycobacterial antigens and identified as latent tuberculosis infection (LTBI). Targeted tuberculin testing for latent TB infection is a very important strategy to identify subjects with high risk to develop tuberculosis including those who have recent infection with Mycobacterium tuberculosis or have clinical conditions that associated with an increased risk for progression of LTBI to active TB but the sensitivity was lower in elderly patients.
Read more
Quantiferon-TB gold test (QFT-RD1) is a new diagnostic test for latent tuberculosis and a valuable alternative to skin testing. This whole-blood assay measures the production of IFN- in whole blood upon stimulation by ESAT-6 and CFP-10 and allows distinction of latent M. tuberculosis infection from BCG-induced reactivity. ESAT-6 and CFP-10 are deleted from BCG Region 1 (RD1), not present in most nontuberculous mycobacteria and are highly specific indicators of M. tuberculosis infection. Thus, the aim of this study was to estimate the specificity and sensitivity of a whole blood IFN-γassay employing CFP-10 and ESAT-6, for the detection of M. tuberculosis infection in a clustered high risk elderly population.
Changhwa Veterans Home is a government-expense veterans home with totally 519 residents in 2004.The inhabitants were all elderly people and lived in groups. , They did not receive BCG vaccination and were the high risk group to develop endemic TB infection. The annual TB incidence rate over there was 3,500 per 100,000 population.
Read the detailed description
STUDY POPULATION AND METHODS Population The study population represented individuals screened for TB over a 6-month period ending in December 2004 as part of a number of community health outreach programs based at the Center of Disease Control in Taichung, Taiwan. Changhwa Veterans Home is a government-expense veterans home with totally 519 residents in 2004. Only individuals with a properly read TST and signed informed consent were included in the study population. If a TST was positive, further evaluation for TB was advised. Anyone found to have active TB infection (12 individuals diagnosed, all from household contacts) was appropriately treated and were also included from the study. No general population low-risk controls were included in the study population. There were no other entry exclusions for the study. Before the TST was administered, a short interview including verbal consent and a BCG scar count evaluation was conducted by an experienced nurse.
The TST contained 2 tuberculin units (TU) of RT23 tuberculin with Tween 80 (0.2 ml of 1TU/0.1 ml) given intradermally on the left forearm volar surface by Mantoux technique. Validity measures such as inter-observer performance were done for TST placement or interpretation individually by two experienced nurse. A purified protein derivative-Siebert (PPD-S) dose of 5TU is roughly equivalent to the 2TU of RT23. 2TU is the International Union Against Tuberculosis and Lung Disease recommended dose for RT23 TST. TST was also performed on BCG-vaccinated health care workers . After 48-72 h of injection, the TST site should be evaluated for induration and a transverse measurement was recorded. Any readings made outside of the above time period were excluded from the study. All unvaccinated subjects had their blood drawn for the QFT-RD1 the same time with applying the first TST. A TST reaction size of ≧10 mm was interpreted as a 'positive' TST which guided any further medical evaluation. This is the traditional cutoff point used for RT23 tuberculin in Taiwan as well as in most studies worldwide. If initial TST diameter less than 10 mm, second TST was repeated within 1-5 weeks to observe any 'boosting phenomenon' was possible. Statistical analysis of skin test results for each population characteristic was done at this cut-off point, with the exception of one analysis specifically done at≧18 mm in BCG-vaccinated health care workers.
Household contacts of active TB patients were presumably at highest risk for TB infection; the group was labeled 'household contact'. No active TB cases have been reported among these residents for years.
- Conditions
- Tuberculosis, Latent Tuberculosis, Tuberculosis Contact, Elderly
- Being tested
- tuberculin for skin test
- Keywords
- tuberculosis, latent tuberculosis, tuberculin skin test, quantiferon TB-RD1, contact screening, elderly
- 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.
tuberculin for skin testDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
tuberculin skin test positive rate
quantiferon positive rate
Secondary outcomes (2)
two steps tuberculin skin test
active tuberculosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startJan 2004
- Study completionNov 2006
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 Taichung Veterans General HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, ChungHwa Veterans house, Taiwan Province Tau-Wein Hospital
- Investigators
- Shen Gwan Han, MD, Principal investigator, Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311220
- Sponsor's protocol ID
- TCVGH-940117/439
- Status last verified
- Apr 2006
- First submitted
- 3 Apr 2006
- Last updated
- 5 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of the Quantiferon-RD1 Test
- ClinicalTrials.gov ID
- NCT00311220
- Acronym / sponsor ID
- TCVGH-940117/439
- Conditions
- Tuberculosis, Latent Tuberculosis, Tuberculosis Contact, Elderly
- Keywords
- tuberculosis, latent tuberculosis, tuberculin skin test, quantiferon TB-RD1, contact screening, elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, ChungHwa Veterans house, Taiwan Province Tau-Wein Hospital
- Study start
- Jan 2004
- Study completion
- Nov 2006
- First posted
- 5 Apr 2006 (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.
Tuberculosis is still the most common infectious disease in Taiwan. The infants in Taiwan have been vaccinated at birth with BCG -Tokyo 171 strain since 1951. The BCG vaccination rate is 97% among first grade students in a recent national survey. Even with such a high BCG vaccination coverage, Taiwan still has a relatively high TB incidence rate. In 2004, there were totally 16,784 newly diagnosed TB cases and the annual incidence was 74.11 per 100,000 population nationally. Nearly 70% of the incidence cases were men and 30.4% were women. The mean age of incidence cases was 57.8 years old (median=63). 8,440(50.29%) patients were elderly than 65 years old. The elderly men did not receive the BCG vaccination and were the most important group to develop newly diagnosed tuberculosis and a special issue for the national TB control program in Taiwan.
The tuberculin skin test (TST) is the only widely available method for detecting whether people have an immunologic reactivity to mycobacterial antigens and identified as latent tuberculosis infection (LTBI). Targeted tuberculin testing for latent TB infection is a very important strategy to identify subjects with high risk to develop tuberculosis including those who have recent infection with Mycobacterium tuberculosis or have clinical conditions that associated with an increased risk for progression of LTBI to active TB but the sensitivity was lower in elderly patients.
Quantiferon-TB gold test (QFT-RD1) is a new diagnostic test for latent tuberculosis and a valuable alternative to skin testing. This whole-blood assay measures the production of IFN- in whole blood upon stimulation by ESAT-6 and CFP-10 and allows distinction of latent M. tuberculosis infection from BCG-induced reactivity. ESAT-6 and CFP-10 are deleted from BCG Region 1 (RD1), not present in most nontuberculous mycobacteria and are highly specific indicators of M. tuberculosis infection. Thus, the aim of this study was to estimate the specificity and sensitivity of a whole blood IFN-γassay employing CFP-10 and ESAT-6, for the detection of M. tuberculosis infection in a clustered high risk elderly population.
Changhwa Veterans Home is a government-expense veterans home with totally 519 residents in 2004.The inhabitants were all elderly people and lived in groups. , They did not receive BCG vaccination and were the high risk group to develop endemic TB infection. The annual TB incidence rate over there was 3,500 per 100,000 population.
Detailed description
STUDY POPULATION AND METHODS Population The study population represented individuals screened for TB over a 6-month period ending in December 2004 as part of a number of community health outreach programs based at the Center of Disease Control in Taichung, Taiwan. Changhwa Veterans Home is a government-expense veterans home with totally 519 residents in 2004. Only individuals with a properly read TST and signed informed consent were included in the study population. If a TST was positive, further evaluation for TB was advised. Anyone found to have active TB infection (12 individuals diagnosed, all from household contacts) was appropriately treated and were also included from the study. No general population low-risk controls were included in the study population. There were no other entry exclusions for the study. Before the TST was administered, a short interview including verbal consent and a BCG scar count evaluation was conducted by an experienced nurse.
The TST contained 2 tuberculin units (TU) of RT23 tuberculin with Tween 80 (0.2 ml of 1TU/0.1 ml) given intradermally on the left forearm volar surface by Mantoux technique. Validity measures such as inter-observer performance were done for TST placement or interpretation individually by two experienced nurse. A purified protein derivative-Siebert (PPD-S) dose of 5TU is roughly equivalent to the 2TU of RT23. 2TU is the International Union Against Tuberculosis and Lung Disease recommended dose for RT23 TST. TST was also performed on BCG-vaccinated health care workers . After 48-72 h of injection, the TST site should be evaluated for induration and a transverse measurement was recorded. Any readings made outside of the above time period were excluded from the study. All unvaccinated subjects had their blood drawn for the QFT-RD1 the same time with applying the first TST. A TST reaction size of ≧10 mm was interpreted as a 'positive' TST which guided any further medical evaluation. This is the traditional cutoff point used for RT23 tuberculin in Taiwan as well as in most studies worldwide. If initial TST diameter less than 10 mm, second TST was repeated within 1-5 weeks to observe any 'boosting phenomenon' was possible. Statistical analysis of skin test results for each population characteristic was done at this cut-off point, with the exception of one analysis specifically done at≧18 mm in BCG-vaccinated health care workers.
Household contacts of active TB patients were presumably at highest risk for TB infection; the group was labeled 'household contact'. No active TB cases have been reported among these residents for years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- people close contact with active tuberculosis patients including health care workers, people in the veterans home, and/or the close contact family or high risk area or county
- low risk volunteers : the clerk and interns doctors initially in the hospital training
Key exclusion criteria (1 listed)
- HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tuberculin for skin test | Drug | – |
Primary outcome
tuberculin skin test positive rate
quantiferon positive rate
2 secondary outcomes
two steps tuberculin skin test
active tuberculosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2006.
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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.
Shen Gwan Han, MD principal investigator
Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tuberculin for skin test in people with Tuberculosis and Latent Tuberculosis, run by Taichung Veterans General Hospital at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Apr 2006. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shen Gwan Han, MD (+886-4-23592525 ext. 3217, 911B@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tuberculin skin test positive rate. The study lists 2 primary outcomes in all. 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 5 Apr 2006.