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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03153384
Acronym
UniEndo
Enrollment
269
Registered
2017-05-15
Start date
2017-11-11
Completion date
2022-07-08
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteremia, Infective Endocarditis

Keywords

Diagnosis, Blood Culture

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.

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).

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Compared performance of a single high volume blood culture vs. multiple blood culture of usual volume for the diagnosis of infective endocarditisAt the end of the hospitalization, or at the time of death if occurred during hospitalization; i.e. an average of 6 weeks after the inclusionSensitivity/Specificity/Accuracy of positive bloodculture sets vs. final diagnosis assessed by the medical team (gold standard)

Secondary

MeasureTime frameDescription
Diagnostic performance of the single high volume blood culture for the diagnosis of infective endocarditisAt the end of the hospitalization, or at the time of death if occurred during hospitalization; i.e. an average of 6 weeks after the inclusionaccording to the level of suspicion of infective endocarditis, the type of microorganism involved, the underlying cardiopathy.
Measuring the nursing time required for both sampling methods.At T0, i.e. at the inclusion of the patientTime for blood culture setting, processing and sending
Diagnosis of infective endocarditis: confirmed, possible or excludedAt the end of the hospitalization, or at the time of death if occurred during hospitalization; i.e. an average of 6 weeks after the inclusionApplying the Classification of Duke-Li according to the modified diagnostic criteria of the European Society of Cardiology Recommendations 2015.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026