EndocarditisNCT00166023
Outcomes Following Medical or Surgical Management of Endocarditis
An observational study of Endocarditis, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endocarditis
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who do not have documented endocarditis based upon microbiology and echocardiography criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: 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.
Read the 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.
- Conditions
- Endocarditis
- Keywords
- pediatric, cardiology
- Medical subject headings
- Endocarditis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startAug 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndocarditisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Kogon, Emory University
- Investigators
- Paul Kirshbom, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166023
- Sponsor's protocol ID
- 0549-2005
- Status last verified
- Nov 2013
- First submitted
- 12 Sep 2005
- Last updated
- 26 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Review of Outcomes Following Medical or Surgical Management of Endocarditis
- ClinicalTrials.gov ID
- NCT00166023
- Acronym / sponsor ID
- 0549-2005
- Conditions
- Endocarditis
- Keywords
- pediatric, cardiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Dec 2006
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who do not have documented endocarditis based upon microbiology and echocardiography criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Kirshbom, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocarditis, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2013.