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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01179451
First received: August 10, 2010
Last updated: February 19, 2013
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Post Streptococcal Reactive Arthritis
 Device: echocardiogram

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Late Cardial Assessment in Children Who Were Diagnosed With Post Streptococcal Reactive Arthritis - a Long Term Study

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • cardiac valve function [ Time Frame: at least 1 year after termination of antibiotic treatment ] [ Designated as safety issue: No ]

Enrollment: 146
Study Start Date: September 2010
Study Completion Date: August 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Post streptococcal reactive arthritis (PSRA)
children who were diagnosed with psra at least one year before the study
 Device: echocardiogram
echocardiogram

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

out patient rheumatology clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179451

Locations
Israel
Meir medical center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01179451     History of Changes
Other Study ID Numbers: MMC10040-10CTIL
Study First Received: August 10, 2010
Last Updated: February 19, 2013
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Additional relevant MeSH terms:
Arthritis
Arthritis, Reactive
Joint Diseases
Musculoskeletal Diseases
Arthritis, Infectious
Infection
 Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases

ClinicalTrials.gov processed this record on June 18, 2013