Personalized Medicine in Patients With Infective Endocarditis

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

• Study Contact: Name: Raquel Rodríguez-García, MD, PhD; Phone Number: 985652433; Email: rrg@crit-lab.org

Study Locations

• Spain
  • Principado De Asturias
    • Oviedo, Principado De Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with an active infective endocarditis

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of the underlying pathogens of infective endocarditis (IE)	We will employ next-generation sequencing for pathogens and antimicrobial resistance detection in IE patients.	2 year
Host response classification for infective endocarditis (IE)	Differential baseline expression of some genes may indicate resilience to infection.	2 year
Host response predictors of sepsis outcomes	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.	2 year

Collaborators and Investigators

• Sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias
• Investigators: Study Director: Guillermo Muñiz Albaiceta, MD, PhD, HUCA-FINBA, Universidad de Oviedo

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Infections; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Cardiovascular Infections; Endocarditis, Bacterial; Endocarditis; Acute-Phase Reaction
• Other Study ID Numbers: FINBA_critlab_4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

All datasets underlying the study are available upon request to the study principal investigator.

All of the individual participant data collected during the trial, informed consent forms, study protocol, statistical analysis plan and raw data, are available under reasonable request, and after deindentification.

• IPD Sharing Time Frame: Starting 3 month after publication
• IPD Sharing Access Criteria: Principal investigator will review requests of data to be provided.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No