Personalized Medicine in Patients With Infective Endocarditis

Treatment Clinical Trial

Official title:

Personalized Medicine in Patients With Infective Endocarditis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04838938
• Other study ID #: FINBA_critlab_4
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: October 2023
• Source: Fundación para la Investigación Biosanitaria del Principado de Asturias
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 1, 2023
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy

Related Conditions & MeSH terms

• Acute-Phase Reaction
• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis
• Response, Acute Phase
• Treatment

Locations

Country	Name	City	State
Spain	Hospital Universitario Central de Asturias	Oviedo	Principado De Asturias

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Investigación Biosanitaria del Principado de Asturias

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize a cohort of patients diagnosed with infective endocarditis	Clinical, microbiological and echocardiographic description of patients with infective endocarditis.	2 year
Secondary	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
Secondary	Host response classification for infective endocarditis (IE)	Differential baseline expression of some genes may indicate resilience to infection.	2 year
Secondary	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