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Etiology of Endocarditis in Negative Blood Cultures (ENDOC)

Primary Purpose

Infective Endocarditis (IE)

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infective Endocarditis (IE)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with endocarditis diagnostic kit prescribed
  • Patient is more than 18 years old
  • Patient who freely signed written informed consent.
  • Patient affiliated to a health assurance

Exclusion Criteria:

  • Minor patient (<18 years)
  • Patient pregnant or breastfeeding
  • Patient incapable or unable to consent
  • Private patient of liberty or under court order
  • Patient refusing to participate in the research

Sites / Locations

  • Assitance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Infective endocarditis

Arm Description

Outcomes

Primary Outcome Measures

The percentage of patients with an etiological diagnosis of endocarditis

Secondary Outcome Measures

The "admission" score
the Duke score

Full Information

First Posted
June 21, 2016
Last Updated
April 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02816307
Brief Title
Etiology of Endocarditis in Negative Blood Cultures
Acronym
ENDOC
Official Title
Etiology of Endocarditis in Negative Blood Cultures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 7, 2013 (Actual)
Primary Completion Date
March 6, 2019 (Actual)
Study Completion Date
October 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Infective endocarditis remains a serious disease that requires fast and specialized support in 2012. However, 24% of endocarditis unanswered etiology. The systematic use of new policy diagnosis, including (i) a systematic use of specific PCR techniques and (ii) the search for markers of inflammatory and tumoral diseases, should increase the number of positive etiological diagnosis of culture-negative samples. Secondly, because of the seriousness of the disease, the investigators were led to develop a new score: score for admission. This score, realized in less than 4 hours from the admission of the suspected patient with endocarditis, should allow for immediate probabilistic antibiotic treatment after completion of the diagnostic kit. The modified Duke score give its results in 4 to 7 days. With the score of admission thus diagnostic processes are accelerated and, where appropriate, empirical antibiotic therapy started. Primary: Evaluate the effectiveness of the new diagnostic strategy on etiological identification of endocarditis. Secondary: Validate the "admission" score compared to the modified Duke score.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infective Endocarditis (IE)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3033 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infective endocarditis
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
blood samples
Primary Outcome Measure Information:
Title
The percentage of patients with an etiological diagnosis of endocarditis
Time Frame
6 years
Secondary Outcome Measure Information:
Title
The "admission" score
Time Frame
1 day
Title
the Duke score
Time Frame
1day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with endocarditis diagnostic kit prescribed Patient is more than 18 years old Patient who freely signed written informed consent. Patient affiliated to a health assurance Exclusion Criteria: Minor patient (<18 years) Patient pregnant or breastfeeding Patient incapable or unable to consent Private patient of liberty or under court order Patient refusing to participate in the research
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
URIELLE DESALBRES
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
JEAN PAUL CASALTA
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assitance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Etiology of Endocarditis in Negative Blood Cultures

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