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NExt-Generation Sequencing and Cell Culture-based Characterization of S. Aureus in Infective Endocarditis

NCT04257292 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2020-02-06

No results posted yet for this study

Summary

Infective endocarditis is a deadly disease with a mortality rate between 20 and 40%. Antibiotic therapy is of utmost importance. It is primarily guided by microbial results from positive blood culture. However, culture-based microbiological diagnostic can identify the species, but not the strain or the genotypic characteristics of a pathogen. Identifying the strain can be of utmost clinical significance. S. aureus is the most common causative organism of IE worldwide (16%-32%). This pathogen causes massive valve destruction and abscesses, which is strongly dependent on the expression of virulence factors that vary between different S. aureus strains.

Functional characterization of S. aureus and determination of virulence factors can currently be achieved through cell culture-based assays (CCBA). However, these tests are very time consuming and cannot be performed as routine clinical diagnostics. Next Generation Sequencing (NSG) has the potential to identify the genotypic characteristics of the pathogen, which is important to determine its virulent potential.

The aim of this study is to evaluate the possible utilization of NGS in the prediction of virulence factors of S. aureus and to compare it to the virulence factors determined using CCBA.

Hopefully, by comparing the NGS and CCBA, the investigators will get a faster way of determining the possible virulence factors. The NGS method can be further utilized to describe the prevalence of different strains of bacteria in infected valve tissue and blood culture samples. The collected data will serve as a basis for further evaluation of the potentials of NGS-based Diagnosis of IE, as well as a comparison between NGS-guided antibiotic treatment and the standard of care antibiotic treatment.

Conditions

  • Infective Endocarditis
  • Infection Staphylococcal

Sponsors & Collaborators

  • Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany

    collaborator UNKNOWN

  • Jena University Hospital

    lead OTHER

Principal Investigators

  • Mahmoud A Diab, Dr. med. · Jena University Hospital, Clinic for Cardiac and Thoracic Surgery

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2020-02-28
Completion
2020-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04257292 on ClinicalTrials.gov