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

NCT03153384 | Completed DMC

• 1 other identifier: APJ2015/UNIENDO-GOEHRINGER/SKJ
• Study Type: observational
• Target: 269
• Locations: 1 country
• Sites: 8

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.

Conditions

Bacteremia; Infective Endocarditis

Keywords

Diagnosis; Blood Culture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Diagnostic performance of the single high volume blood culture for the diagnosis of infective endocarditis

  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

• Measuring the nursing time required for both sampling methods.

  At T0, i.e. at the inclusion of the patient

• Diagnosis of infective endocarditis: confirmed, possible or excluded

  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

Study Arms (1)

one both experimental and control arm

Each patient experiences two methods of blood cultures.

Procedure: Blood Culture

Interventions

Blood Culture 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).

one both experimental and control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospitalized adult patients suspected of infective endocarditis

You may qualify if:

• 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.

You may not qualify if:

• Antibiotherapy adapted to a situation of endocarditis, introduced more than 24 hours or stopped for less than 7 days in case of therapeutic window.
• State of consciousness not allowing loyal information.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (8)

Hôpital Nord Franche Comté

Belfort, 90000, France

Location

Centre Hospitalier universitaire de Besançon

Besançon, 25000, France

Location

Centre Hospitalier universitaire de Dijon

Dijon, 25000, France

Location

Centre hospitalier Universitaire de Nancy

Nancy, 54511, France

Location

Hopital BIchat Claude Bernard

Paris, 75018, France

Location

Centre Hospitalier Universitaire de Reims

Reims, 51100, France

Location

Centre Hospitalier Univesitaire de Rennes

Rennes, 35000, France

Location

Hôpitaux Civils de Strasbourg

Strasbourg, 67000, France

Location

Related 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.

  PMID: 9060065 BACKGROUND

• 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.

  PMID: 24766148 BACKGROUND

• 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.

  PMID: 26590409 BACKGROUND

• 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.

  PMID: 10770721 BACKGROUND

MeSH Terms

Conditions

Bacteremia; Endocarditis; Disease

Interventions

Blood Culture

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• François Goehringer, MD

  Centre Hospitalier Universitaire de Nancy, Nancy, France

  PRINCIPAL INVESTIGATOR

• Xavier Duval, MD PhD

  APHP, Hôpital Bichat Claude Bernard, Paris, France.

  STUDY CHAIR

• Christine Selton-Suty, MD

  Centre Hospitalier Universitaire de Nancy, Nancy, France

  STUDY CHAIR

• Nejla Aissa, MD

  Centre Hospitalier Universitaire de Nancy, Nancy, France

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 15, 2017
• Study Start: November 11, 2017
• Primary Completion: May 5, 2022
• Study Completion: July 8, 2022
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)