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Completed

NCT Number: NCT04838938

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.

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Key information

Conditions

Infective Endocarditis Acute-Phase Reaction Cardiovascular Diseases Endocarditis Heart Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Response, Acute Phase Treatment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy

Treatment and study plan

Primary outcomes

  1. To characterize a cohort of patients diagnosed with infective endocarditis

    Time frame: 2 year

    Clinical, microbiological and echocardiographic description of patients with infective endocarditis.

Secondary outcomes

  1. Identification of the underlying pathogens of infective endocarditis (IE)

    Time frame: 2 year

    We will employ next-generation sequencing for pathogens and antimicrobial resistance detection in IE patients.

  2. Host response classification for infective endocarditis (IE)

    Time frame: 2 year

    Differential baseline expression of some genes may indicate resilience to infection.

  3. Host response predictors of sepsis outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación Biosanitaria del Principado de Asturias

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 9, 2021
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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