Etiology of Endocarditis in Negative Blood Cultures

Infective Endocarditis (IE) Clinical Trial

— ENDOC  

Official title:

Etiology of Endocarditis in Negative Blood Cultures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816307
• Other study ID #: 2012-39
• Secondary ID: 2012-A01549-34
• Status: Completed
• Phase: N/A
• Start date: June 7, 2013
• Est. completion date: October 26, 2022

Study information

• Verified date: April 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3033
• Est. completion date: October 26, 2022
• Est. primary completion date: March 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis (IE)

Intervention

Other:
• blood samples

Locations

Country	Name	City	State
France	Assitance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients with an etiological diagnosis of endocarditis		6 years
Secondary	The "admission" score		1 day
Secondary	the Duke score		1day