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

Tuberculosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756808
• Other study ID #: 07-050
• Status: Completed
• Phase: N/A
• First received: September 19, 2008
• Last updated: February 6, 2014
• Start date: October 2007
• Est. completion date: July 2010

Study information

• Verified date: February 2014
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Latent Tuberculosis
• Tuberculosis

Locations

Country	Name	City	State
United States	Staten Island University Hospital	Staten Island	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Staten Island University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection of latent TB		2 years	No