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Etiology of Endocarditis in Negative Blood Cultures (ENDOC)

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ClinicalTrials.gov Identifier: NCT02816307
Recruitment Status : Recruiting
First Posted : June 28, 2016
Last Update Posted : June 28, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Infective Endocarditis (IE) Other: blood samples Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1830 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Etiology of Endocarditis in Negative Blood Cultures
Study Start Date : March 2013
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis

Arm Intervention/treatment
Experimental: Infective endocarditis Other: blood samples



Primary Outcome Measures :
  1. The percentage of patients with an etiological diagnosis of endocarditis [ Time Frame: 6 years ]

Secondary Outcome Measures :
  1. The "admission" score [ Time Frame: 1 day ]
  2. the Duke score [ Time Frame: 1day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816307


Contacts
Contact: jean-paul CASALTA jeanpaul.casalta@ap-hm.fr
Contact: ALEXANDRA GIULIANI alexandra.giuliani@ap-hm.fr

Locations
France
Assitance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13
Contact: jean paul casalta    0491387587    jeanpaul.casalta@ap-hm.fr   
Principal Investigator: jean-paul casalta         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: URIELLE DESALBRES Assistance Publique Hopitaux De Marseille
Principal Investigator: JEAN PAUL CASALTA Assistance Publique Hopitaux De Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02816307     History of Changes
Other Study ID Numbers: 2012-39
2012-A01549-34 ( Other Identifier: ANSM )
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Endocarditis
Endocarditis, Bacterial
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection