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CompletedNCT03153384UniEndoUpdated Mar 19, 2024

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

An observational study in Bacteremia and Infective Endocarditis, sponsored by Central Hospital, Nancy, France. Completed at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
269
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bacteremia
  • Infective Endocarditis

Keywords

  • Diagnosis
  • Blood Culture
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Hospitalized adult patients suspected of infective endocarditis

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

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.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
269 participants (actual)
Target follow-up
6 Weeks
Patient registry
Yes

Groups and cohorts

  • one both experimental and control arm

    Each patient experiences two methods of blood cultures.

    Procedure: Blood Culture

Interventions

  • ProcedureBlood 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).

05

What researchers measure

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)

    Time frame: 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

  1. 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.

    Time frame: 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

  2. Measuring the nursing time required for both sampling methods.

    Time for blood culture setting, processing and sending

    Time frame: At T0, i.e. at the inclusion of the patient

  3. 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.

    Time frame: 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

06

Study locations

8 sites
  • Hôpital Nord Franche Comté
    Belfort, 90000, France
  • Centre Hospitalier universitaire de Besançon
    Besancon, 25000, France
  • Centre Hospitalier universitaire de Dijon
    Dijon, 25000, France
  • Centre hospitalier Universitaire de Nancy
    Nancy, 54511, France
  • Hopital BIchat Claude Bernard
    Paris, 75018, France
  • Centre Hospitalier Universitaire de Reims
    Reims, 51100, France
  • Centre Hospitalier Univesitaire de Rennes
    Rennes, 35000, France
  • Hôpitaux Civils de Strasbourg
    Strasbourg, 67000, France
07

References and documents

Publications

  • 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. PubMed 9060065 ↗
  • 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. PubMed 24766148 ↗
  • 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. PubMed 26590409 ↗
  • 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. PubMed 10770721 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03153384
Lead sponsor
Central Hospital, Nancy, France
Responsible party
GOEHRINGER François (Dr, Central Hospital, Nancy, France) — Principal investigator
First posted
May 15, 2017
Start date
Nov 11, 2017
Primary completion
May 5, 2022
Completion
Jul 8, 2022
Last update
Mar 19, 2024

Study contacts

François Goehringer, MD
principal investigator · Centre Hospitalier Universitaire de Nancy, Nancy, France
Xavier Duval, MD PhD
study chair · APHP, Hôpital Bichat Claude Bernard, Paris, France.
Christine Selton-Suty, MD
study chair · Centre Hospitalier Universitaire de Nancy, Nancy, France
Nejla Aissa, MD
study chair · Centre Hospitalier Universitaire de Nancy, Nancy, France

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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