ClinicalTrials.gg
CompletedNCT04838938Updated Oct 5, 2023

Personalized Medicine in Patients With Infective Endocarditis

An observational study in Infective Endocarditis, Response, Acute Phase and Treatment, sponsored by Fundación para la Investigación Biosanitaria del Principado de Asturias. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-05.

Sponsored by Fundación para la Investigación Biosanitaria del Principado de Asturias · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
32
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Infective Endocarditis
  • Response, Acute Phase
  • Treatment
03

In context

Endocarditis

173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.

This study's enrollment of 32 is below the median of 225 across 82 observational studies indexed under Endocarditis.

Browse Endocarditis studies →

Lead sponsor

Fundación para la Investigación Biosanitaria del Principado de Asturias is the lead sponsor of 12 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with an active infective endocarditis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
32 participants (actual)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

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

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

    Time frame: 2 year

Secondary outcomes

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

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

    Time frame: 2 year

  2. Host response classification for infective endocarditis (IE)

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

    Time frame: 2 year

  3. 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.

    Time frame: 2 year

07

Study locations

1 site
  • Hospital Universitario Central de Asturias
    Oviedo, Principado De Asturias 33011, Spain
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: Starting 3 month after publication

Access criteria: Principal investigator will review requests of data to be provided.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04838938
Lead sponsor
Fundación para la Investigación Biosanitaria del Principado de Asturias
Responsible party
Sponsor
First posted
Apr 9, 2021
Start date
Mar 1, 2021
Primary completion
Mar 1, 2022
Completion
Jul 1, 2023
Last update
Oct 5, 2023

Study contacts

Guillermo Muñiz Albaiceta, MD, PhD
study director · HUCA-FINBA, Universidad de Oviedo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion