Personalized Medicine in Patients With Infective Endocarditis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04838938

Enrollment

Registered

2021-04-09

Start date

2021-03-01

Completion date

2023-07-01

Last updated

2023-10-05

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

Conditions

Infective Endocarditis, Response, Acute Phase, Treatment

Brief summary

The hypothesis underlying this work is the identification of different sub phenotypes of patients with infective endocarditis through the study of the host's response to infection. Furthemore, metagenomic sequencing may be a helpful supplement to IE diagnostic, especially when conventional tests fail to yield a diagnosis.

Detailed description

Infective endocarditis is a life-threatening infection of heart valves and adjacent structures characterized by vegetations on valves and other endocardial surfaces, with tissue destruction and risk of embolization. The clinical variability, including the heterogeneous response to infection and the different antibiotic treatments make the identification of the underlying pathogens of infective endocarditis (IE) is critical for precision therapy. Virulence factors mediate tissue adherence, host infiltration, immune resistance/evasion, and dynamic stress responses and confer enhanced pathogen survival, proliferation, and host invasion in animal models of infective endocarditis. To identify the microorganism and simultaneously considered the response of the host to the infection could improve the management of the infective endocarditis.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of active infective endocarditis according to the modified Duke criteria.

Exclusion criteria

* Pregnancy

Design outcomes

Primary

Measure	Time frame	Description
To characterize a cohort of patients diagnosed with infective endocarditis	2 year	Clinical, microbiological and echocardiographic description of patients with infective endocarditis.

Secondary

Measure	Time frame	Description
Identification of the underlying pathogens of infective endocarditis (IE)	2 year	We will employ next-generation sequencing for pathogens and antimicrobial resistance detection in IE patients.
Host response classification for infective endocarditis (IE)	2 year	Differential baseline expression of some genes may indicate resilience to infection.
Host response predictors of sepsis outcomes	2 year	We will develop and use advanced bioinformatic, metabolomic, proteomic and mRNA sequencing technologies to identify specific changes, or biomarkers, in patient blood samples that predict outcome in sepsis.

Countries

Spain

Outcome results