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

NCT ID: NCT00756808

Last Updated: 2014-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tuberculosis

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Staten Island University Hospital

OTHER

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Donna Seminara

Program Director, Geriatric Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Donna Seminara, MD

Role: PRINCIPAL_INVESTIGATOR

Staten Island University Hospital

Locations

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Staten Island University Hospital

Staten Island, New York, United States

Site Status

Countries

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United States

Other Identifiers

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07-050

Identifier Type: -

Identifier Source: org_study_id

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