NCT00947817

Brief Summary

Prospective study including all the consecutive patients admitted at the Department of Cardiology, Timone Hospital wih a definite diagnosis of IE according to the modified Duke criteria. The period of inclusion will be for 24 months. Eighty patients and age-matched control subject will be included. Primary end point are EE occurring during the antimicrobial treatment and secondary end points will be 6-month mortality, vegetation length and the impact of antimicrobial treatment on inflammation-induced procoagulant changes and endothelial cell activation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 28, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

August 24, 2015

Status Verified

May 1, 2010

Enrollment Period

1.6 years

First QC Date

January 15, 2009

Last Update Submit

August 21, 2015

Conditions

Infective Endocarditis

Outcome Measures

Primary Outcomes (1)

  • Embolic events occurring during the antimicrobial treatment a

    30 months

Secondary Outcomes (1)

  • Will be 6-month mortality, vegetation length and the impact of antimicrobial treatment on inflammation-induced procoagulant changes and endothelial cell activation.

    30months

Study Arms (2)

patient

EXPERIMENTAL
Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test

control

OTHER
Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test

Interventions

ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic testOTHER
controlpatient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All the patients presenting certain diagnosis of infectious endocardite according to the criteria of modified Duke

You may not qualify if:

  • Age \< 18 years
  • Pregnancy and feeding
  • Health not allowing to give the assent
  • Innate abnormalities of the haemostasis
  • More than a week before the inclu antibiothérapie adapted begun

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département de Cardiologie, Unité Valvulopathies et Insuffisance Cardiaque, Hôpital de la Timone,

Marseille, Paca, 13, France

Location

MeSH Terms

Conditions

Endocarditis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • franck thuny

    Assistance Publique Hopitaux De Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2009

First Posted

July 28, 2009

Study Start

September 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

August 24, 2015

Record last verified: 2010-05

Locations

FR(1)