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NCT Number: NCT03153384

Impact of the Blood Culture Technique on the Diagnosis 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Nord Franche Comté, Belfort, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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

    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)

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: UniEndo

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
May 15, 2017
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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