Clinical trial NCT03153384: Impact of the Blood Culture Technique on the Diagnosis of Infective Endocarditis
Official title: Impact of the Blood Culture Technique on the Diagnosis of Infectious Diseases: Case of Infective Endocarditis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Infective Endocarditis
Keywords: Diagnosis
Blood Culture
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized adult patients suspected of infective endocarditis

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Compared performance of a single high volume blood culture vs. multiple blood culture of usual volume for the diagnosis of infective endocarditis
timeFrame: 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 outcomes:
measure: Diagnostic performance of the single high volume blood culture for the diagnosis of infective endocarditis
timeFrame: 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: Measuring the nursing time required for both sampling methods.
timeFrame: At T0, i.e. at the inclusion of the patient
measure: Diagnosis of infective endocarditis: confirmed, possible or excluded
timeFrame: 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
Other outcomes:
Locations:
city: Belfort
country: France
facility: Hôpital Nord Franche Comté
city: Besancon
country: France
facility: Centre Hospitalier universitaire de Besançon
city: Dijon
country: France
facility: Centre Hospitalier universitaire de Dijon
city: Nancy
country: France
facility: Centre hospitalier Universitaire de Nancy
city: Paris
country: France
facility: Hopital BIchat Claude Bernard
city: Reims
country: France
facility: Centre Hospitalier Universitaire de Reims
city: Rennes
country: France
facility: Centre Hospitalier Univesitaire de Rennes
city: Strasbourg
country: France
facility: Hôpitaux Civils de Strasbourg
Study officials:
affiliation: Centre Hospitalier Universitaire de Nancy, Nancy, France
name: François Goehringer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: APHP, Hôpital Bichat Claude Bernard, Paris, France.
name: Xavier Duval, MD PhD
role: STUDY_CHAIR
affiliation: Centre Hospitalier Universitaire de Nancy, Nancy, France
name: Christine Selton-Suty, MD
role: STUDY_CHAIR
affiliation: Centre Hospitalier Universitaire de Nancy, Nancy, France
name: Nejla Aissa, MD
role: STUDY_CHAIR
References:
citation: 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.
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.
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.
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.