Clinical Metagenomics of Infective Endocarditis

NCT03199287 | Completed

• 1 other identifier: 2017-00114
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Infective Endocarditis

Keywords

metagenomics; next-generation sequencing; bioinformatics; antibiotic susceptibility

Outcome Measures

Primary Outcomes (1)

• Diagnostic of IE

  The diagnostic of IE obtained by conventional methods and by clinical metagenomics

  24 months

Secondary Outcomes (3)

• Number of species identified by conventional methods but not by clinical metagenomics

  24 months

• Number of species not identified by conventional methods but found in clinical metagenomics

  24 months

• Inference of antibiotic susceptibility

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patient undergoing valvular surgery in the context of suspicion of IE.

You may qualify if:

• 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.

You may not qualify if:

• Opposition of the patient to participate in the study.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 26, 2017
• Study Start: June 8, 2017
• Primary Completion: December 31, 2020
• Study Completion: March 30, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)