Infective EndocarditisNCT04838938
Personalized Medicine in Patients With Infective Endocarditis
An observational study of Infective Endocarditis and Response, Acute Phase, run by Fundación para la Investigación Biosanitaria del Principado de Asturias at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis, Response, Acute Phase, Treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2021to 1 Jul 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an active infective endocarditis
Who may be able to join
- Diagnosis of active infective endocarditis according to the modified Duke criteria.
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
About this study
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.
- Conditions
- Infective Endocarditis, Response, Acute Phase, Treatment
- Medical subject headings
- Endocarditis, Acute-Phase Reaction
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize a cohort of patients diagnosed with infective endocarditis
Clinical, microbiological and echocardiographic description of patients with infective endocarditis.
Measured: 2 year
Secondary outcomes (3)
Identification of the underlying pathogens of infective endocarditis (IE)
We will employ next-generation sequencing for pathogens and antimicrobial resistance detection in IE patients.
Measured: 2 year
Host response classification for infective endocarditis (IE)
Differential baseline expression of some genes may indicate resilience to infection.
Measured: 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.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Mar 2021
- Primary completion1 Mar 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación Biosanitaria del Principado de Asturias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillermo Muñiz Albaiceta, MD, PhD, Study director, HUCA-FINBA, Universidad de Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838938
- Sponsor's protocol ID
- FINBA_critlab_4
- Status last verified
- Oct 2023
- First submitted
- 26 Mar 2021
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Medicine in Patients With Infective Endocarditis
- ClinicalTrials.gov ID
- NCT04838938
- Acronym / sponsor ID
- FINBA_critlab_4
- Conditions
- Infective Endocarditis, Response, Acute Phase, Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fundación para la Investigación Biosanitaria del Principado de AsturiasUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an active infective endocarditis
Key inclusion criteria (1 listed)
- Diagnosis of active infective endocarditis according to the modified Duke criteria.
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To characterize a cohort of patients diagnosed with infective endocarditis
Time frame: 2 year
Clinical, microbiological and echocardiographic description of patients with infective endocarditis.
3 secondary outcomes
Identification of the underlying pathogens of infective endocarditis (IE)
Time frame: 2 year
Host response classification for infective endocarditis (IE)
Time frame: 2 year
Host response predictors of sepsis outcomes
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: 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.
Related trials for Infective Endocarditis
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Metabolic Profiling Among Patients Suspected of Infective Endocarditis - PPSIE Comparing Metabolomes of Bloodstream Infections Versus Infective Endocarditis
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Recruiting
CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
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RecruitingObservational study
Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients
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Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prosthetic Valve Endocarditis
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AngioVac Aspiration Therapy Registry
Intracardiac Thrombus, Intracardiac Mass
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Muñiz Albaiceta, MD, PhD study director
HUCA-FINBA, Universidad de Oviedo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infective Endocarditis and Response, Acute Phase, run by Fundación para la Investigación Biosanitaria del Principado de Asturias at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize a cohort of patients diagnosed with infective endocarditis (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.