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Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis (TB) in Elderly Residents of Nursing Homes?

This study has been completed.
Sponsor:
Collaborator:
Staten Island University Hospital
Information provided by (Responsible Party):
Donna Seminara, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00756808
First received: September 19, 2008
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

In face of the increased rates of tuberculosis in residents of long term care facilities, annual screening for latent tuberculosis is recommended. Tuberculin skin testing using purified protein derivative (PPD) is used for this purpose. Sensitivity of the PPD testing is, however, dependent on a normal T cell function. It is now evident that the immune system undergoes age-associated alteration known as immune senescence. The depressed T-cell responses may clinically manifest as attenuated delayed-type hypersensitivity. This attenuated reaction may affect the sensitivity of the PPD in detection of latent TB in the elderly.

This prospective study will examine the utility of interferon-gamma (IFN-γ) based assay, T-SPOT.TB, for detection of latent tuberculosis in nursing home patients who are 65 years of age or older.


Condition
Tuberculosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Is Tuberculin Skin Testing Effective in Screening for Latent TB in Elderly Residents of Nursing Homes? Comparison With a New IFN-y Based Assay

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • detection of latent TB [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: October 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

65 and older

Criteria

Inclusion Criteria:

  • 65 years of age and older
  • No ulcerating or blistering skin disorder
  • No previous history of adverse reaction to PPD testing
  • No blood transfusion within 6 weeks prior to enrollment
  • If the participant had a PPD placed and read by a public health department representative within the last 6 months, repeat PPD will not be done, but the person may participate in the study
  • Participant may have been Bacille de Calmette et Guerin (BCG)-vaccinated

Exclusion Criteria:

  • Less than 65 years
  • Not a resident of a long term care facility
  • Diagnosis of Tuberculosis
  • blood transfusion within 6 weeks of enrollment
  • Prior diagnosis of immune deficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756808

Locations
United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Staten Island University Hospital
Investigators
Principal Investigator: Donna Seminara, MD Staten Island University Hospital
  More Information

No publications provided

Responsible Party: Donna Seminara, Program Director, Geriatric Medicine, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00756808     History of Changes
Other Study ID Numbers: 07-050
Study First Received: September 19, 2008
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
latent tuberculosis in elderly

Additional relevant MeSH terms:
Latent Tuberculosis
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections

ClinicalTrials.gov processed this record on November 20, 2014