Characterization of Endocarditis to Streptococci and Impa... | NCT03306225

Studies
Characterization of Endocarditis to Streptococci and Impact of the CMI on the Future of the Patients

NCT03306225

Sponsor

Fondation Hôpital Saint-Joseph

Status

Completed

Last Update Posted

Feb 5, 2020Actual

Enrollment

414Actual

Phase

Not provided

Conditions

Endocarditis, Bacterial

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 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 8, 2016Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Oct 5, 2017

First Submission Date that Met QC Criteria

Oct 9, 2017

First Posted Date

Oct 10, 2017Actual

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 3, 2020

Last Update Posted Date

Feb 5, 2020Actual

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

The infectious endocarditis is a grave infection the incidence of which is at present esteemed at 30-100 episodes by million inhabitants a year.

This infection is marked with a heavy morbi-mortality.Preliminary studies seem to show an abnormally high death rate at the patients presenting an infectious endocarditis to streptococci with an inhibitive minimal concentration raised to the amoxicilline. The aim of the study is to describe the epidemiology and the clinical presentations of the patients presenting an endocarditis to streptococci

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

414Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of factors associated to the mortality in the patients presenting an endocarditis to streptococci.		an average of one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > 18 years
endocartitis with steptococci with Duke's criteria

Exclusion Criteria:

age < 18 years
suspiscious endocarditis without Duke's criteria

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

all patient diagnostised for endocarditis between 2010 and 2015

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
PILMIS P Benoit, MD	Fondation Hôpital Saint-Joseph	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Paris Saint Joseph		Paris	Île-de-France Region	75014	France

Condition Browse Module

MeSH Terms

ID	Term
D004697	Endocarditis, Bacterial

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D053821	Cardiovascular Infections

Browse Leaves

Not provided

Browse Branches

Not provided