Etiology of Endocarditis in Negative Blood Cultures

Not Applicable

Completed

• Conditions: Infective Endocarditis (IE)
• Interventions: Other: blood samples

• Registration Number: NCT02816307
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-07
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-28
• Primary Completion: 2019-03-06
• Study Completion: 2022-10-26
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3033

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infective endocarditis	blood samples	-

Primary Outcome Measures

Name	Time	Method
The percentage of patients with an etiological diagnosis of endocarditis	6 years

Secondary Outcome Measures

Name	Time	Method
The "admission" score	1 day
the Duke score	1day

Trial Locations

Locations (1)

Assitance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France