NCT01179451

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2010

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 20, 2013

Status Verified

March 1, 2012

Enrollment Period

11 months

First QC Date

August 10, 2010

Last Update Submit

February 19, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • cardiac valve function

    at least 1 year after termination of antibiotic treatment

Study Arms (1)

Post streptococcal reactive arthritis (PSRA)

children who were diagnosed with psra at least one year before the study

Device: echocardiogram

Interventions

echocardiogram

Post streptococcal reactive arthritis (PSRA)

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

out patient rheumatology clinic

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir medical center

Kfar Saba, Israel

Location

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2010

First Posted

August 11, 2010

Study Start

September 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2012

Last Updated

February 20, 2013

Record last verified: 2012-03

Locations