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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
  • 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

    Recruiting

Other trials in China

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.

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.

  1. tuberculin skin test positive rate

  2. quantiferon positive rate

Secondary outcomes (2)
  1. two steps tuberculin skin test

  2. active tuberculosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2006 (estimated)
  2. Study startJan 2004
  3. Study completionNov 2006

Resources

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
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

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.

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