Etiology of Endocarditis in Negative Blood Cultures (ENDOC)

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.

Study Overview

• Status: Completed
• Conditions: Infective Endocarditis (IE)
• Intervention / Treatment: Other: blood samples

• Study Type: Interventional
• Enrollment (Actual): 3033
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: jean-paul CASALTA; Email: jeanpaul.casalta@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13
    • Assitance Publique Hôpitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infective endocarditis	Other: blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percentage of patients with an etiological diagnosis of endocarditis	6 years

Secondary Outcome Measures

Outcome Measure	Time Frame
The "admission" score	1 day
the Duke score	1day

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2013
• Primary Completion (Actual): March 6, 2019
• Study Completion (Actual): October 26, 2022

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: June 24, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Cardiovascular Infections; Endocarditis, Bacterial; Endocarditis
• Other Study ID Numbers: 2012-39; 2012-A01549-34 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO