Late Cardial Assessment in Children Who Were Diagnosed With Post Streptococcal Reactive Arthritis - a Long Term Study

February 19, 2013 updated by: Meir Medical Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

out patient rheumatology clinic

Description

Inclusion Criteria:

  • PSRA patients under 18 who were diagnosed at least one year prior to the study

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post streptococcal reactive arthritis (PSRA)
children who were diagnosed with psra at least one year before the study
Device: echocardiogram
echocardiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cardiac valve function
Time Frame: at least 1 year after termination of antibiotic treatment
at least 1 year after termination of antibiotic treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

August 10, 2010

First Submitted That Met QC Criteria

August 10, 2010

First Posted (Estimate)

August 11, 2010

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 19, 2013

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC10040-10CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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