Viewing Study NCT00166023



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Last Modification Date: 2024-10-26 @ 9:15 AM
Study NCT ID: NCT00166023
Status: COMPLETED
Last Update Posted: 2013-11-26
First Post: 2005-09-12

Brief Title: Outcomes Following Medical or Surgical Management of Endocarditis
Sponsor: Emory University
Organization: Emory University

Study Overview

Official Title: A Review of Outcomes Following Medical or Surgical Management of Endocarditis
Status: COMPLETED
Status Verified Date: 2013-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Infective endocarditis is a rare disease and while there have been several large reviews of the incidence of endocarditis in the pediatric patient population relatively little has been published regarding the short and medium-term outcomes following medical and surgical therapy for this disease The goal is to compare the outcome for children treated for endocarditis with either medical management or surgery by looking at the success of these two treatment strategies Another goal is to attempt to identify risk factors for medical management that might identify patients who would be better served by early surgery
Detailed Description: After identification of qualified subjects the families of surviving patients will be mailed a package containing a cover letter explaining the study a consent form an assent form if applicable a questionnaire designed to evaluate longer-term outcome measures including the occurrence of recurrent endocarditis late surgical intervention or the need for re-operations and a self addressed stamped envelope to be used to return the consents and the questionnaire The data will then be entered into a database and analyzed

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None