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

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ClinicalTrials.gov Identifier: NCT00756808
Recruitment Status : Completed
First Posted : September 22, 2008
Last Update Posted : February 7, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Tuberculosis

Study Design

Study Type : Observational
Actual Enrollment : 135 participants
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
Study Start Date : October 2007
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. detection of latent TB [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756808


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

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
First Posted: September 22, 2008    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014

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

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