TuberculosisNCT00551226
Follow up of Autoantibodies in Active Tuberculosis
An observational study of Tuberculosis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
We have previoulsy shown that patients with active Tuberculosis develop a wide array of autoantibodies including rheumatoid factor, anti-CCP, Antinuclear facyor and anti Sm antibodies. The purpose of this study is to evaluate whether the level of autoantibodies decrease after treatment aganist tuberculosis. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2007to Nov 2008
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with active tuberculosis who are currently receiving anti tuberculosis drugs
Who may be able to join
- Active Tuberculosis treated
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel Aviv Medical Center
Tel Aviv, Tel Aviv, 64239
Ori Elkayam, M.D, 97236973668, oribe14@netvision.net.il
About this study
We have previoulsy shown that patients with active Tuberculosis develop a wide array of autoantibodies including rheumatoid factor, anti-CCP, Antinuclear facyor and anti Sm antibodies. The purpose of this study is to evaluate whether the level of autoantibodies decrease after treatment aganist tuberculosis.
- Conditions
- Tuberculosis
- Keywords
- TB, Patients with tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with tuberculosis | |
| 2 | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow up after levels of autoantibodies
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startNov 2007
- Study completionNov 2008 (estimated)
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 Tel-Aviv Sourasky Medical CenterThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Ori Elkayam, M.D, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551226
- Sponsor's protocol ID
- 314-07
- Status last verified
- Oct 2007
- First submitted
- 27 Oct 2007
- Last updated
- 30 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up of Autoantibodies in Active Tuberculosis
- ClinicalTrials.gov ID
- NCT00551226
- Acronym / sponsor ID
- 314-07
- Conditions
- Tuberculosis
- Keywords
- TB, Patients with tuberculosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Nov 2007
- Study completion
- Nov 2008 (estimated)
- First posted
- 30 Oct 2007 (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.
We have previoulsy shown that patients with active Tuberculosis develop a wide array of autoantibodies including rheumatoid factor, anti-CCP, Antinuclear facyor and anti Sm antibodies. The purpose of this study is to evaluate whether the level of autoantibodies decrease after treatment aganist tuberculosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with tuberculosis |
| 2 | – | –Healthy controls |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with active tuberculosis who are currently receiving anti tuberculosis drugs
Key inclusion criteria (1 listed)
- Active Tuberculosis treated
Key exclusion criteria (1 listed)
- None
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
Follow up after levels of autoantibodies
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2007.
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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.
Ori Elkayam, M.D principal investigator
Tel Aviv Medical Center
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 Tel-Aviv Sourasky Medical Center at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Oct 2007. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ori Elkayam, M.D (97236973668, oribe14@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follow up after levels of autoantibodies (time frame: 1 year). 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 30 Oct 2007.