Impact of the Blood Culture Technique on the Diagnosis of Infective Endocarditis (UniEndo)

March 18, 2024 updated by: GOEHRINGER François, Central Hospital, Nancy, France

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

269

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Hospitalized adult patients suspected of infective endocarditis

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
one both experimental and control arm
Each patient experiences two methods of blood cultures.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compared performance of a single high volume blood culture vs. multiple blood culture of usual volume for the diagnosis of infective endocarditis
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of infective endocarditis: confirmed, possible or excluded
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
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
Diagnostic performance of the single high volume blood culture for the diagnosis of infective endocarditis
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
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
Measuring the nursing time required for both sampling methods.
Time Frame: At T0, i.e. at the inclusion of the patient
Time for blood culture setting, processing and sending
At T0, i.e. at the inclusion of the patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: François Goehringer, MD, Centre Hospitalier Universitaire de Nancy, Nancy, France
  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2017

Primary Completion (Actual)

May 5, 2022

Study Completion (Actual)

July 8, 2022

Study Registration Dates

First Submitted

May 5, 2017

First Submitted That Met QC Criteria

May 12, 2017

First Posted (Actual)

May 15, 2017

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APJ2015/UNIENDO-GOEHRINGER/SKJ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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