Impact of the Blood Culture Technique on the Diagnosis of Infective Endocarditis

Bacteremia Clinical Trial

— UniEndo  

Official title:

Impact of the Blood Culture Technique on the Diagnosis of Infectious Diseases: Case of Infective Endocarditis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03153384
• Other study ID #: APJ2015/UNIENDO-GOEHRINGER/SKJ
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Bacteremia
• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

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