Bacteremia Clinical Trial
— UniEndoOfficial title:
Impact of the Blood Culture Technique on the Diagnosis of Infectious Diseases: Case of Infective Endocarditis.
Verified date | March 2024 |
Source | Central Hospital, Nancy, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 269 |
Est. completion date | July 8, 2022 |
Est. primary completion date | May 5, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Nord Franche Comté | Belfort | |
France | Centre Hospitalier universitaire de Besançon | Besancon | |
France | Centre Hospitalier universitaire de Dijon | Dijon | |
France | Centre hospitalier Universitaire de Nancy | Nancy | |
France | Hopital BIchat Claude Bernard | Paris | |
France | Centre Hospitalier Universitaire de Reims | Reims | |
France | Centre Hospitalier Univesitaire de Rennes | Rennes | |
France | Hôpitaux Civils de Strasbourg | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
France,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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