Management of Infectious Endocarditis as Part of a Multid... | NCT03429153

Studies
Management of Infectious Endocarditis as Part of a Multidisciplinary Consensus Meeting

NCT03429153

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Feb 12, 2018Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Endocarditis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 5, 2018Actual

Primary Completion Date

Aug 2018Estimated

Completion Date

Aug 2018Estimated

First Submitted Date

Jan 5, 2018

First Submission Date that Met QC Criteria

Feb 9, 2018

First Posted Date

Feb 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2018

Last Update Posted Date

Feb 12, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

New ESC 2015 recommendations with encouragement to set up a Multidisciplinary Consultation Meeting to discuss the medical and surgical management of endocarditis, set up at Strasbourg University Hospital in October 2016: Impact and benefits

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Measure	Description	Time Frame
Mortality rate		up to 1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age over 18 18 years at diagnosis
Diagnosis of confirmed Infectious Endocarditis
Medical and / or surgical care at Strasbourg University Hospital between January 2007 and June 2018

Exclusion Criteria:

- Refusal to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Diagnosis of confirmed Infectious Endocarditis
Medical and / or surgical care at Strasbourg University Hospital between January 2007 and June 2018

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xavier ARGEMI, MD	Contact	33 3 69 55 11 87		xavier.argemi@chru-strasbourg.fr
Yvon RUCH, MD	Contact	33 3 69 55 11 87		yvon.ruch@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Xavier ARGEMI, MD	University Hospital, Strasbourg, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Maladies Infectieuses et Tropicales	Recruiting	Strasbourg		67091	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004696	Endocarditis

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided