Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Outcomes Following Medical or Surgical Management of Endocarditis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian Kogon, Emory University
ClinicalTrials.gov Identifier:
NCT00166023
First received: September 12, 2005
Last updated: November 25, 2013
Last verified: November 2013

September 12, 2005
November 25, 2013
August 2005
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00166023 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Outcomes Following Medical or Surgical Management of Endocarditis
A Review of Outcomes Following Medical or Surgical Management of Endocarditis

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.

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.

Observational
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Endocarditis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2006
Not Provided

Inclusion Criteria:

  • All patients discharged from Children's Healthcare of Atlanta at Egleston with a discharge diagnosis of endocarditis or those who underwent surgery with a preoperative diagnosis of endocarditis.
  • Admitted to the hospital between January 1, 1984 - December 31, 2004, inclusive.
  • Signed informed consent.

Exclusion Criteria:

  • Patients who do not have documented endocarditis based upon microbiology and echocardiography criteria.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00166023
0549-2005
Not Provided
Brian Kogon, Emory University
Emory University
Not Provided
Principal Investigator: Paul Kirshbom, MD Emory University
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP