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

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ClinicalTrials.gov Identifier: NCT03153384
Recruitment Status : Not yet recruiting
First Posted : May 15, 2017
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.

Condition or disease Intervention/treatment
Bacteremia Infective Endocarditis Procedure: Blood Culture

Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Weeks
Official Title: Impact of the Blood Culture Technique on the Diagnosis of Infectious Diseases: Case of Infective Endocarditis.
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis

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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hospitalized adult patients suspected of infective endocarditis
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153384


Contacts
Contact: François Goehringer, MD +33 383154098 f.goehringer@chru-nancy.fr

Locations
France
Centre Hospitalier universitaire de Besançon Not yet recruiting
Besancon, France, 25000
Contact: Catherine Chirouze, MD PhD         
Centre Hospitalier de Charleville Mézière Not yet recruiting
Charleville Mézière, France, 08000
Contact: Delphine Lebrun, MD         
Centre Hospitalier universitaire de Dijon Not yet recruiting
Dijon, France, 25000
Contact: Lionel Piroth, MD PhD         
Centre Hospitalier Emile Durkheim Not yet recruiting
Epinal, France, 88000
Contact: Loic Bourdelon, MD         
Centre hospitalier Universitaire de Nancy Not yet recruiting
Nancy, France, 54511
Contact: François Goehringer    +33 3 83154098    f.goehringer@chru-nancy.fr   
Centre Hospitalier Universitaire de Reims Not yet recruiting
Reims, France, 51100
Contact: Yohan NGuyen, MD PhD         
groupe Courlancy
Reims, France, 51100
Hôpitaux Civils de Strasbourg Not yet recruiting
Strasbourg, France, 67000
Contact: Xavier Argemi, MD         
Sponsors and Collaborators
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:
Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03153384     History of Changes
Other Study ID Numbers: APJ2015/UNIENDO-GOEHRINGER/SKJ
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Central Hospital, Nancy, France:
Diagnosis
Blood Culture

Additional relevant MeSH terms:
Endocarditis
Endocarditis, Bacterial
Bacterial Infections
Infection
Cardiovascular Infections
Bacteremia
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Heart Diseases
Cardiovascular Diseases