Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis (TB) in Elderly Residents of Nursing Homes?
1 other identifier
observational
135
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 19, 2008
CompletedFirst Posted
Study publicly available on registry
September 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFebruary 7, 2014
February 1, 2014
2.8 years
September 19, 2008
February 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
detection of latent TB
2 years
Eligibility Criteria
65 and older
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
- Staten Island University Hospitalcollaborator
Study Sites (1)
Staten Island University Hospital
Staten Island, New York, 10305, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donna Seminara, MD
Staten Island University Hospital
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Program Director, Geriatric Medicine
Study Record Dates
First Submitted
September 19, 2008
First Posted
September 22, 2008
Study Start
October 1, 2007
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
February 7, 2014
Record last verified: 2014-02