TuberculosisNCT00756808
Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis (TB) in Elderly Residents of Nursing Homes?
An observational study of Tuberculosis, run by Northwell Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: 65 and older
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hospital
Staten Island, New York, 10305
About this study
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
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.
- Conditions
- Tuberculosis
- Keywords
- latent tuberculosis in elderly
- Medical subject headings
- Tuberculosis
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of latent TB
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startOct 2007
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Staten Island University Hospital
- Responsible party
- Principal investigator, Donna Seminara, Northwell Health
- Investigators
- Donna Seminara, MD, Principal investigator, Staten Island University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756808
- Sponsor's protocol ID
- 07-050
- Status last verified
- Feb 2014
- First submitted
- 19 Sep 2008
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00756808
- Acronym / sponsor ID
- 07-050
- Conditions
- Tuberculosis
- Keywords
- latent tuberculosis in elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Staten Island University Hospital
- Study start
- Oct 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- 65 and older
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
detection of latent TB
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Seminara, MD principal investigator
Staten Island University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of latent TB (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2014.