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CompletedNCT02816307ENDOCUpdated Apr 21, 2023

Etiology of Endocarditis in Negative Blood Cultures

An interventional study of blood samples in Infective Endocarditis (IE), sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-21.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Jun 2013, registered Jun 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
3,033
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Infective Endocarditis (IE)

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03

In context

Endocarditis

173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.

This study's enrollment of 3,033 is above the median of 92 across 86 interventional studies indexed under Endocarditis.

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Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient with endocarditis diagnostic kit prescribed
  • Patient is more than 18 years old
  • Patient who freely signed written .
  • Patient affiliated to a health assurance

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3,033 participants (actual)

Study arms

  • Experimental
    Infective endocarditis

    Other: blood samples

Interventions

  • Otherblood samples
06

What researchers measure

Primary outcomes

  1. The percentage of patients with an etiological diagnosis of endocarditis

    Time frame: 6 years

Secondary outcomes

  1. The "admission" score

    Time frame: 1 day

  2. the Duke score

    Time frame: 1day

07

Study locations

1 site
  • Assitance Publique Hopitaux de Marseille
    Marseille, 13, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02816307
Responsible party
Sponsor
First posted
Jun 28, 2016
Start date
Jun 7, 2013
Primary completion
Mar 6, 2019
Completion
Oct 26, 2022
Last update
Apr 21, 2023

Study contacts

URIELLE DESALBRES
study director · Assistance Publique Hopitaux De Marseille
JEAN PAUL CASALTA
principal investigator · Assistance Publique Hopitaux De Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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