Personalized Medicine in Patients With Infective Endocarditis
1 other identifier
observational
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
March 26, 2021
CompletedFirst Posted
Study publicly available on registry
April 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedOctober 5, 2023
October 1, 2023
1 year
March 26, 2021
October 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
To characterize a cohort of patients diagnosed with infective endocarditis
Clinical, microbiological and echocardiographic description of patients with infective endocarditis.
2 year
Secondary Outcomes (3)
Identification of the underlying pathogens of infective endocarditis (IE)
2 year
Host response classification for infective endocarditis (IE)
2 year
Host response predictors of sepsis outcomes
2 year
Eligibility Criteria
Patients with an active infective endocarditis
You may qualify if:
- Diagnosis of active infective endocarditis according to the modified Duke criteria.
You may not qualify if:
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Biospecimen
Samples with DNA for the study of the host's sub phenotypes Plasma and heart valves to make a metagenomic sequencing
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Guillermo Muñiz Albaiceta, MD, PhD
HUCA-FINBA, Universidad de Oviedo
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2021
First Posted
April 9, 2021
Study Start
March 1, 2021
Primary Completion
March 1, 2022
Study Completion
July 1, 2023
Last Updated
October 5, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Starting 3 month after publication
- Access Criteria
- Principal investigator will review requests of data to be provided.
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.