Etiology of Endocarditis in Negative Blood Cultures

NCT ID: NCT02816307

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3033 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-07
• Study Completion Date: 2022-10-26

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.

Conditions

Infective Endocarditis (IE)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Infective endocarditis

Group Type: EXPERIMENTAL

blood samples

Intervention Type: OTHER

Interventions

blood samples

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

URIELLE DESALBRES

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

JEAN PAUL CASALTA

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hopitaux De Marseille

Locations

Assitance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2012-A01549-34

Identifier Type: OTHER

Identifier Source: secondary_id

2012-39

Identifier Type: -

Identifier Source: org_study_id