Etiology of Endocarditis in Negative Blood Cultures

NCT02816307 | Completed

• 2 other identifiers: 2012-392012-A01549-34
• Study Type: interventional
• Target: 3,033
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• The percentage of patients with an etiological diagnosis of endocarditis

  6 years

Secondary Outcomes (2)

• The "admission" score

  1 day

• the Duke score

  1day

Study Arms (1)

Infective endocarditis

EXPERIMENTAL

Other: blood samples

Interventions

blood samples OTHER

Infective endocarditis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assitance Publique Hopitaux de Marseille

Marseille, 13, France

Location

MeSH Terms

Conditions

Endocarditis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• URIELLE DESALBRES

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

• JEAN PAUL CASALTA

  Assistance Publique Hopitaux De Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 28, 2016
• Study Start: June 7, 2013
• Primary Completion: March 6, 2019
• Study Completion: October 26, 2022
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)