Post Streptococcal Reactive ArthritisNCT01179451
Late Cardial Assessment in Children Who Were Diagnosed With Post Streptococcal Reactive Arthritis - a Long Term Study
An observational study of Post Streptococcal Reactive Arthritis, run by Meir Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether there is late cardial involvement in children diagnosed with post streptococcal reactive arthritis after discontinuation of prophylactic antibiotic therapy. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Post Streptococcal Reactive Arthritis
- What is being tested?
- echocardiogram
- Type of treatment
- Medical device
- How many people
- 146 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to Aug 2012
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: out patient rheumatology clinic
Who may be able to join
- PSRA patients under 18 who were diagnosed at least one year prior to the study
Who cannot join
- PSRA patients under 18 who were diagnosed less one year prior to the study
- patients who do not fulfill PSRA criteria
- patients who fulfill Jones criteria
- patients with a known heart defect
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether there is late cardial involvement in children diagnosed with post streptococcal reactive arthritis after discontinuation of prophylactic antibiotic therapy.
- Conditions
- Post Streptococcal Reactive Arthritis
- Being tested
- echocardiogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiogramDevice
echocardiogram
| Study group | Role | What they receive |
|---|---|---|
| Post streptococcal reactive arthritis (PSRA) | children who were diagnosed with psra at least one year before the study Receives: Device: echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac valve function
Measured: at least 1 year after termination of antibiotic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Streptococcal Reactive ArthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179451
- Sponsor's protocol ID
- MMC10040-10CTIL
- Status last verified
- Mar 2012
- First submitted
- 10 Aug 2010
- Last updated
- 20 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Cardial Assessment in Children Who Were Diagnosed With Post Streptococcal Reactive Arthritis - a Long Term Study
- ClinicalTrials.gov ID
- NCT01179451
- Acronym / sponsor ID
- MMC10040-10CTIL
- Conditions
- Post Streptococcal Reactive Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 11 Aug 2010 (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 purpose of this study is to determine whether there is late cardial involvement in children diagnosed with post streptococcal reactive arthritis after discontinuation of prophylactic antibiotic therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post streptococcal reactive arthritis (PSRA) | – | Device: echocardiogramchildren who were diagnosed with psra at least one year before the study |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- out patient rheumatology clinic
Key inclusion criteria (1 listed)
- PSRA patients under 18 who were diagnosed at least one year prior to the study
Key exclusion criteria (4 listed)
- PSRA patients under 18 who were diagnosed less one year prior to the study
- patients who do not fulfill PSRA criteria
- patients who fulfill Jones criteria
- patients with a known heart defect
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 |
|---|---|---|
| echocardiogramechocardiogram | Device | Post streptococcal reactive arthritis (PSRA) |
Primary outcome
cardiac valve function
Time frame: at least 1 year after termination of antibiotic treatment
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 20 Feb 2013.
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.
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 Post Streptococcal Reactive Arthritis, run by Meir 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 4 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 20 Feb 2013. 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?
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?
cardiac valve function (time frame: at least 1 year after termination of antibiotic treatment). 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 20 Feb 2013.