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

This study is ongoing, but not recruiting participants.

First Received: September 19, 2008 Last Updated: March 24, 2009 History of Changes

Sponsored by:	Staten Island University Hospital
Information provided by:	Staten Island University Hospital
ClinicalTrials.gov Identifier:	NCT00756808

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

MedlinePlus related topics: Nursing Homes Tuberculosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	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

Further study details as provided by Staten Island University Hospital:

Primary Outcome Measures:

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

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	138
Study Start Date:	October 2007
Estimated Primary Completion Date:	January 2009 (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 BCG-vaccinated

Contacts and Locations

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

Staten Island University Hospital

More Information

No publications provided

Responsible Party:	Staten Island University Hospital ( Dr. Donna Seminara )
Study ID Numbers:	07-050
Study First Received:	September 19, 2008
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00756808 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Staten Island University Hospital:

latent tuberculosis in elderly

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Tuberculosis

Additional relevant MeSH terms:

Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Tuberculosis
Actinomycetales Infections

ClinicalTrials.gov processed this record on May 07, 2009