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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| one both experimental and control arm | Each patient experiences two methods of blood cultures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Culture | Procedure | For each patient, one single high volume blood culture (3 aerobic and 3 anaerobic of 8 to 10 mL each, numbered), and then 2 samples of 16 to 20 mL (one aerobic bottle and one anaerobic for each sample). |
| Measure | Description | Time Frame |
|---|---|---|
| Compared performance of a single high volume blood culture vs. multiple blood culture of usual volume for the diagnosis of infective endocarditis | Sensitivity/Specificity/Accuracy of positive bloodculture sets vs. final diagnosis assessed by the medical team (gold standard) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of the single high volume blood culture for the diagnosis of infective endocarditis | according to the level of suspicion of infective endocarditis, the type of microorganism involved, the underlying cardiopathy. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitalized adult patients suspected of infective endocarditis
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| Name | Affiliation | Role |
|---|---|---|
| François Goehringer, MD | Centre Hospitalier Universitaire de Nancy, Nancy, France | Principal Investigator |
| Xavier Duval, MD PhD | APHP, Hôpital Bichat Claude Bernard, Paris, France. | Study Chair |
| Christine Selton-Suty, MD | Centre Hospitalier Universitaire de Nancy, Nancy, France | Study Chair |
| Nejla Aissa, MD | Centre Hospitalier Universitaire de Nancy, Nancy, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Nord Franche Comté | Belfort | 90000 | France | |||
| Centre Hospitalier universitaire de Besançon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9060065 | Background | Arendrup M, Jensen IP, Justesen T. Diagnosing bacteremia at a Danish hospital using one early large blood volume for culture. Scand J Infect Dis. 1996;28(6):609-14. doi: 10.3109/00365549609037969. | |
| 24766148 | Background | Dargere S, Parienti JJ, Roupie E, Gancel PE, Wiel E, Smaiti N, Loiez C, Joly LM, Lemee L, Pestel-Caron M, du Cheyron D, Verdon R, Leclercq R, Cattoir V; UBC study group. Unique blood culture for diagnosis of bloodstream infections in emergency departments: a prospective multicentre study. Clin Microbiol Infect. 2014 Nov;20(11):O920-7. doi: 10.1111/1469-0691.12656. Epub 2014 Jun 14. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 10, 2025 | |
| Reset | Jun 24, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 10, 2025 | Jun 24, 2025 |
| ID | Term |
|---|---|
| D016470 | Bacteremia |
| D004696 | Endocarditis |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
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| ID | Term |
|---|---|
| D000071997 | Blood Culture |
| ID | Term |
|---|---|
| D008828 | Microbiological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Measuring the nursing time required for both sampling methods. | Time for blood culture setting, processing and sending | At T0, i.e. at the inclusion of the patient |
| Diagnosis of infective endocarditis: confirmed, possible or excluded | Applying the Classification of Duke-Li according to the modified diagnostic criteria of the European Society of Cardiology Recommendations 2015. | 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 |
| Besançon |
| 25000 |
| France |
| Centre Hospitalier universitaire de Dijon | Dijon | 25000 | France |
| Centre hospitalier Universitaire de Nancy | Nancy | 54511 | France |
| Hopital BIchat Claude Bernard | Paris | 75018 | France |
| Centre Hospitalier Universitaire de Reims | Reims | 51100 | France |
| Centre Hospitalier Univesitaire de Rennes | Rennes | 35000 | France |
| Hôpitaux Civils de Strasbourg | Strasbourg | 67000 | France |
| 26590409 | Background | The 2015 ESC Guidelines for the management of infective endocarditis. Eur Heart J. 2015 Nov 21;36(44):3036-7. doi: 10.1093/eurheartj/ehv488. |
| 10770721 | Background | Li JS, Sexton DJ, Mick N, Nettles R, Fowler VG Jr, Ryan T, Bashore T, Corey GR. Proposed modifications to the Duke criteria for the diagnosis of infective endocarditis. Clin Infect Dis. 2000 Apr;30(4):633-8. doi: 10.1086/313753. Epub 2000 Apr 3. |
| D018746 |
| Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008919 | Investigative Techniques |