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

NCT ID: NCT03153384

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

269 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-11

Study Completion Date

2022-07-08

Brief Summary

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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.

Detailed Description

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Conditions

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Bacteremia Infective Endocarditis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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one both experimental and control arm

Each patient experiences two methods of blood cultures.

Blood Culture

Intervention Type 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).

Interventions

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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).

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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GOEHRINGER François

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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François Goehringer, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nancy, Nancy, France

Xavier Duval, MD PhD

Role: STUDY_CHAIR

APHP, Hôpital Bichat Claude Bernard, Paris, France.

Christine Selton-Suty, MD

Role: STUDY_CHAIR

Centre Hospitalier Universitaire de Nancy, Nancy, France

Nejla Aissa, MD

Role: STUDY_CHAIR

Centre Hospitalier Universitaire de Nancy, Nancy, France

Locations

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Hôpital Nord Franche Comté

Belfort, , France

Site Status

Centre Hospitalier universitaire de Besançon

Besançon, , France

Site Status

Centre Hospitalier universitaire de Dijon

Dijon, , France

Site Status

Centre hospitalier Universitaire de Nancy

Nancy, , France

Site Status

Hopital BIchat Claude Bernard

Paris, , France

Site Status

Centre Hospitalier Universitaire de Reims

Reims, , France

Site Status

Centre Hospitalier Univesitaire de Rennes

Rennes, , France

Site Status

Hôpitaux Civils de Strasbourg

Strasbourg, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 9060065 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24766148 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26590409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10770721 (View on PubMed)

Other Identifiers

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APJ2015/UNIENDO-GOEHRINGER/SKJ

Identifier Type: -

Identifier Source: org_study_id

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