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Clinical Metagenomics of Infective Endocarditis (Meta-ENDO)

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ClinicalTrials.gov Identifier: NCT03199287
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Jacques SCHRENZEL, University Hospital, Geneva

Brief Summary:

Infective endocarditis (IE) is an infection of cardiac valves. IE mainly involves bacteria, more rarely fungi. IE is an uncommon diseases with an estimated incidence of 1-12 cases per 100,000 inhabitants per year. The diagnostic of IE relies on the culture of biological samples (blood cultures and per-operative samples) in the bacteriology laboratory in order to identify the pathogen and its susceptibility to antimicrobials. Nonetheless in about 10% of the cases, the blood cultures remain negative, due to antibiotics taken before harvesting, to non-culturable bacteria or to aseptic phenomena.

Clinical metagenomics is defined as the application of high-throughput sequencing (NGS) followed by a specific bioinformatics analysis to obtain clinical information, i.e. pathogen identification and the prediction of their susceptibility to antimicrobials. The metagenome of a sample (i.e. all the genomes of the organisms present) virtually contains all the information necessary for bacteriological diagnosis: what is the pathogenic bacteria , and to which antibiotics it is susceptible.

Hence, using clinical metagenomics in the context of IE appears seducing in order to overcome the limitations of conventional methods based on culture. Here, we propose to assess the performance of clinical metagenomics in the diagnostic of IE.


Condition or disease
Infective Endocarditis

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Metagenomics of Infective Endocarditis
Actual Study Start Date : June 8, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis




Primary Outcome Measures :
  1. Diagnostic of IE [ Time Frame: 24 months ]
    The diagnostic of IE obtained by conventional methods and by clinical metagenomics


Secondary Outcome Measures :
  1. Number of species identified by conventional methods but not by clinical metagenomics [ Time Frame: 24 months ]
    Number of species identified by conventional methods but not by clinical metagenomics

  2. Number of species not identified by conventional methods but found in clinical metagenomics [ Time Frame: 24 months ]
    Number of species not identified by conventional methods but found in clinical metagenomics

  3. Inference of antibiotic susceptibility [ Time Frame: 24 months ]
    For each antibiotic, number of patients for whom prediction of bacterial sensitivity agrees with the sensitivity data obtained by conventional methods.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Adult patient undergoing valvular surgery in the context of suspicion of IE.
Criteria

Inclusion criteria

The criteria for inclusion of patients are:

  • Age over 18 years-old
  • Patient operated for valvular surgery in a context of suspected IE.
  • Collection of per-operative samples sent to the central bacteriological laboratory for the purpose of establishing a microbiological diagnosis.
  • Obtaining the consent of the patient.

Exclusion criteria

The exclusion criteria are:

  • Opposition of the patient to participate in the study.
  • Insufficient quantity (<500 μL) of sampling to perform conventional analyzes and DNA extraction in this project (may be a secondary exclusion criterion if the patient has already given consent).

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): NCT03199287


Contacts
Contact: Jacques Schrenzel, MD +41 22 372 73 23 jacques.schrenzel@hcuge.ch
Contact: Stéphane Emonet, MD +41 22 372 73 23 stephane.emonet@hcuge.ch

Locations
Switzerland
Geneva University Hospitals Recruiting
Genève, Switzerland, 1211
Contact: Jacques Schrenzel, MD    +41 22 3727308    jacques.schrenzel@hcuge.ch   
Contact: Stéphane Emonet, MD    +41 22 372 73 23    stephane.emonet@hcuge.ch   
Sponsors and Collaborators
University Hospital, Geneva

Responsible Party: Prof. Jacques SCHRENZEL, Prof, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03199287     History of Changes
Other Study ID Numbers: 2017-00114
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 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 Prof. Jacques SCHRENZEL, University Hospital, Geneva:
metagenomics
next-generation sequencing
bioinformatics
antibiotic susceptibility

Additional relevant MeSH terms:
Endocarditis
Endocarditis, Bacterial
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection