Impact of the Blood Culture Technique on the Diagnosis of Infective Endocarditis
- Conditions
- Infective EndocarditisBacteremia
- Interventions
- Procedure: Blood Culture
- Registration Number
- NCT03153384
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
To evaluate the performance of a single high volume blood culture sampling strategy versus the actually used multiple sampling strategy for the diagnosis and categorization of infective endocarditis according to the Duke-Li classification in a Population of adults suspected of infective endocarditis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 269
- Patients older than 18 years
- Suspected endocarditis: Patients with Duke-Li-ESC 2015 classification as a major morphological criterion or at least two minor criteria, other than a microbiological criterion, will be considered suspicious of infectious endocarditis.
- Not objecting to their inclusion in the study after delivery and explanation of the information form.
- Absence of microbiological documentation sought or available at the time of inclusion (a patient having already had negative blood cultures or being identified during the screening can be included).
- Antibiotherapy adapted to a situation of endocarditis, introduced more than 24 hours or stopped for less than 7 days in case of therapeutic window.
- Any previous antibiotic therapy in the 7 days preceding the inclusion leading to an improvement in the clinical symptomatology.
- State of consciousness not allowing loyal information.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description one both experimental and control arm Blood Culture Each patient experiences two methods of blood cultures.
- Primary Outcome Measures
Name Time Method Compared performance of a single high volume blood culture vs. multiple blood culture of usual volume for the diagnosis of infective endocarditis At the end of the hospitalization, or at the time of death if occurred during hospitalization; i.e. an average of 6 weeks after the inclusion Sensitivity/Specificity/Accuracy of positive bloodculture sets vs. final diagnosis assessed by the medical team (gold standard)
- Secondary Outcome Measures
Name Time Method Diagnostic performance of the single high volume blood culture for the diagnosis of infective endocarditis At the end of the hospitalization, or at the time of death if occurred during hospitalization; i.e. an average of 6 weeks after the inclusion according to the level of suspicion of infective endocarditis, the type of microorganism involved, the underlying cardiopathy.
Diagnosis of infective endocarditis: confirmed, possible or excluded At the end of the hospitalization, or at the time of death if occurred during hospitalization; i.e. an average of 6 weeks after the inclusion Applying the Classification of Duke-Li according to the modified diagnostic criteria of the European Society of Cardiology Recommendations 2015.
Measuring the nursing time required for both sampling methods. At T0, i.e. at the inclusion of the patient Time for blood culture setting, processing and sending
Trial Locations
- Locations (8)
Hôpital Nord Franche Comté
🇫🇷Belfort, France
Centre hospitalier Universitaire de Nancy
🇫🇷Nancy, France
Hopital BIchat Claude Bernard
🇫🇷Paris, France
Centre Hospitalier universitaire de Dijon
🇫🇷Dijon, France
Centre Hospitalier universitaire de Besançon
🇫🇷Besancon, France
Centre Hospitalier Universitaire de Reims
🇫🇷Reims, France
Centre Hospitalier Univesitaire de Rennes
🇫🇷Rennes, France
Hôpitaux Civils de Strasbourg
🇫🇷Strasbourg, France