Use TST and QFT-RD1 Test to Monitor the Tuberculous Infection in Patients, Close Contact People and Health Care Workers

NCT00311220 | Unknown Phase 4

• 1 other identifier: TCVGH-940117/439
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Tuberculosis; Latent Tuberculosis; Tuberculosis Contact; Elderly

Keywords

tuberculosis; latent tuberculosis; tuberculin skin test; quantiferon TB-RD1; contact screening; elderly

Outcome Measures

Primary Outcomes (2)

• tuberculin skin test positive rate

• quantiferon positive rate

Secondary Outcomes (2)

• two steps tuberculin skin test

• active tuberculosis

Interventions

tuberculin for skin test DRUG

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• HIV

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead
• Centers for Disease Control and Prevention: collaborator
• ChungHwa Veterans house: collaborator
• Taiwan Province Tau-Wein Hospital: collaborator

Study Sites (1)

Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital

Taichung, Taiwan, 407, China

RECRUITING

MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis

Interventions

Tuberculin; Skin Tests

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Intervention Hierarchy (Ancestors)

Antigens, Bacterial; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Shen Gwan Han, MD

  Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shen Gwan Han, MD

CONTACT

+886-4-23592525; 911B@vghtc.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 3, 2006
• First Posted: April 5, 2006
• Study Start: January 1, 2004
• Study Completion: November 1, 2006
• Last Updated: April 5, 2006

Record last verified: 2006-04

Locations

CN (1)