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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03153384
Other study ID # APJ2015/UNIENDO-GOEHRINGER/SKJ
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 11, 2017
Est. completion date July 8, 2022

Study information

Verified date March 2024
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Procedure:
Blood Culture
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).

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (4)

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

Outcome

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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