Personalized Medicine in Patients With Infective Endocarditis

Completed

• Conditions: Infective Endocarditis; Treatment; Response, Acute Phase

• Registration Number: NCT04838938
• Lead Sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias

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.

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-09
• Primary Completion: 2022-03-01
• Study Completion: 2023-07-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Host response classification for infective endocarditis (IE)	2 year	Differential baseline expression of some genes may indicate resilience to infection.
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 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.

Trial Locations

Locations (1)

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Principado De Asturias, Spain