Latent TuberculosisNCT02073669
Latent Tuberculosis in Second Generation Immigrants From High Risk Countries Compare to Low-risk Young Israeli Adults
A study testing Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA) in people with Latent Tuberculosis, run by Sheba Medical Center at 2 sites in Israel.
Trial summary
The aim of study is to evaluate the prevalence of latent TB in second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000) compare to the control native Israelis without a family member who was born in a country with high incidence of tuberculosis. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Latent Tuberculosis
- What is being tested?
- Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 2 sitesIsrael
- Study dates
- Mar 2014to Nov 2018
- Phase
- Interventional
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-25
- Men and women
- Second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000).
- Native Israelis without a family member who was born in a country with high incidence of tuberculosis.
Who cannot join
- Prior contact with a tuberculosis patient
- Working (more than a month) in high risk setting such as health care workers, working with immigrants from countries with high incidence of tuberculosis.
- HIV infection and any immunodeficiency condition.
- Recent live-virus vaccination
- Acute infectious disease
- Prior serious reaction to tuberculin skin test
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Sheba Medical Center
Ramat Gan, 52621
Israeli Defense Forces
Ramat Gan
About this study
Official title: Better Identification of Latent Tuberculosis Infection Among Israeli Young Adults by Comparison Skin Tests and Interferon Gamma Releasing Assays (IGRA)
The aim of study is to evaluate the prevalence of latent TB in second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000) compare to the control native Israelis without a family member who was born in a country with high incidence of tuberculosis. Using study questionnaire IGRA and tuberculin skin test the investigators expect that the second generation immigrants group will have more positive IGRA test than the control native group.
- Conditions
- Latent Tuberculosis
- Being tested
- Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA)
- Keywords
- latent tuberculosis, tuberculin skin test, Interferon gamma release assay, immigration
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Second generation immigrants from high TB incidence countries | Other | Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA). Receives: Procedure: Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA) |
| Native Israelis | Other | Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA). Receives: Procedure: Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interferon gamma release assay ( IGRA)
Measured: Up to 3 months after tuberculin skin test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent TuberculosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv Lung Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073669
- Sponsor's protocol ID
- SHEBA-13-0668-DS-CTIL
- Status last verified
- Jan 2019
- First submitted
- 25 Feb 2014
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Identification of Latent Tuberculosis Infection Among Israeli Young Adults by Comparison Skin Tests and Interferon Gamma Releasing Assays (IGRA)
- ClinicalTrials.gov ID
- NCT02073669
- Acronym / sponsor ID
- SHEBA-13-0668-DS-CTIL
- Conditions
- Latent Tuberculosis
- Keywords
- latent tuberculosis, tuberculin skin test, Interferon gamma release assay, immigration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Tel Aviv Lung Association
- Study start
- Mar 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 27 Feb 2014 (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.
The aim of study is to evaluate the prevalence of latent TB in second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000) compare to the control native Israelis without a family member who was born in a country with high incidence of tuberculosis. Using study questionnaire IGRA and tuberculin skin test the investigators expect that the second generation immigrants group will have more positive IGRA test than the control native group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Second generation immigrants from high TB incidence countries | Other | Procedure: Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA)Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA). |
| Native Israelis | Other | Procedure: Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA)Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-25
- Men and women
- Second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000).
- Native Israelis without a family member who was born in a country with high incidence of tuberculosis.
Key exclusion criteria (7 listed)
- Prior contact with a tuberculosis patient
- Working (more than a month) in high risk setting such as health care workers, working with immigrants from countries with high incidence of tuberculosis.
- HIV infection and any immunodeficiency condition.
- Recent live-virus vaccination
- Acute infectious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA) | Procedure or surgery | Native Israelis, Second generation immigrants from high TB incidence countries |
Primary outcome
Interferon gamma release assay ( IGRA)
Time frame: Up to 3 months after tuberculin skin test
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 25 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA) in people with Latent Tuberculosis, run by Sheba Medical Center at 2 sites in Israel.
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 4 inclusion and 7 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 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Interferon gamma release assay ( IGRA) (time frame: Up to 3 months after tuberculin skin test). 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 25 Jan 2019.