Endocarditis InfectiveASTERIxNCT05061355
Antibiotics Vs Antibiotics and Surgical ThERapy for Infective Endocarditis
A study testing Heart valve surgery in people with Endocarditis Infective, run by Emil Loldrup Fosbol at 15 sites in 4 countries.
Trial summary
Infective endocarditis (IE) is a deadly disease and the incidence is increasing. An important initial assessment of patients with IE includes whether surgical treatment is indicated; yet, appropriate data to guide this assessment do not exist. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Endocarditis Infective
- What is being tested?
- Heart valve surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 496 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 9 Sep 2021to 1 Jun 2026
- Phase
- Interventional
- 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Definite left-sided infective endocarditis defined by the ESC (European Society of Cardiology) modified Duke Criteria
- AND
- Valve vegetation =>10mm AND <=30mm with 1 or no previous embolic event during current IE case
Who cannot join
- Unwilling to sign informed consent
- At least one clear class I recommendation for surgery because of heart failure or uncontrolled local infection (abscess, false aneurysm, fistula)
- Unavailable for follow-up (e.g. tourist)
- OR
- At least one of the following criteria (unsuitable for surgery)
- Intracranial hemorrhage <1 month
Show all 15Show fewer
- Life expectancy <1 year
- Age ≥85 years
- BMI below 15 or above 45
- Possible severe liver cirrhosis (Child-Pugh Class B or worse)
- Clinical frailty score of 5 or above
- EUROSCORE II > 50%
- Severe pulmonary disease (FEV1 (Forced expiratory volume in 1 second) or DLCO (Diffusing capacity for carbon monoxide) <30% of expected)
- Left ventricular ejection fraction (<20%)
- Technically inoperable (e.g. extracorporeal circulation deemed impossible)
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
Denmark9 sites, 9 recruiting
- Recruiting
Aalborg University Hospital
Aalborg
Hanne S Jensen, MD
- Recruiting
Aarhus University Hospital
Aarhus
Jonas Povlsen
- Recruiting
University Hospital of Copenhagen, Rigshospitalet
Copenhagen, 2100
Emil Fosbøl, MD, PhD, +4535456340, emil.fosboel@regionh.dk
- Recruiting
Amager Hvidovre Hospital
Copenhagen
Ekim Seven, MD
- Recruiting
Bispebjerg Hospital
Copenhagen
Nana Køber, MD
- Recruiting
Herlev and Gentofte Hospital
Gentofte Municipality
Kasper Iversen, MD
- Recruiting
Nordsjællands Hospital
Hillerød
Malene Wienberg, MD
- Recruiting
Odense University Hospital
Odense
Kenneth Pedersen, MD
- Recruiting
Zealand University Hospital
Roskilde
Niels E Bruun, MD
Netherlands3 sites, 3 recruiting
- Recruiting
Amsterdam University Medical Center
Amsterdam, 1105
Henneke Gerritsen, Research Nurse/Coordinator Ca, +31 (0) 20 - 444 44 45, j.gerritsen1@amsterdamumc.nl
Jasper L Selder, MD
- Recruiting
Catharina Hospital
Eindhoven, 5623
Ingrid Aarts, Research Coordinator, 040 - 239 83 60, ingrid.aarts@catharinaziekenhuis.nl
Kayan Lam, MD
- Recruiting
Leiden University Medical Center
Leiden
Jesper Hjortnaes, MD
Sweden2 sites, 2 recruiting
- Recruiting
Linköping Heart Center, University Hospital
Linköping, 581 85
Nina Hallsten, MD, 072-4638242, nina.hallsten@regionostergotland.se
Farkas Vánky, MD
- Recruiting
Karolinska Institutet
Stockholm, Solna, 17177
Madeleine Dewerand, Research Coordinator, +46 8-524 833 73, christian.olsson@ki.se
Christian Olsson, MD, PhD
Germany1 site, 1 recruiting
- Recruiting
Leipzig Heart Center
Leipzig, 04289
Maren A Zieger, Study Coordinator, +49 341 865-251545, maren.zieger@leipzig-heart.de
maren.zieger@leipzig-heart.de
About this study
Infective endocarditis (IE) is a deadly disease and the incidence is increasing. An important initial assessment of patients with IE includes whether surgical treatment is indicated; yet, appropriate data to guide this assessment do not exist.
The ASTERIx study will assess whether a surgical approach in addition to medical care for treatment of IE is superior to medical care alone. In total, 496 patients will be included in the study over four years. The study is event-driven and will require at least 240 events. The study will assess the primary composite outcome of death, embolization, relapse of IE, new heart failure or reinfection.
Read more
Study participants who survive to discharge will be followed by routine clinical check-ups at one- and four-weeks post-discharge and at three months. Additionally a 12-month study follow-up is planned.
The investigators will also conduct a small substudy to assess the frequency of silent emboli.
Read the detailed description
Infective endocarditis (IE) is a life-threatening disease and studies suggest that the incidence of IE has almost doubled in the last twenty years. Despite improved disease-management and diagnostics (i.e. antibiotics, surgery, and imaging techniques) IE remains a condition that is hard to diagnose and associated with high mortality (≈1/3 die within one year). Surgery is a key part of the clinical practice in IE, but the role of surgery has been greatly debated and is also used with great variation among centers. Valve repair and replacement are high-risk procedures and per-operative risk is therefore also a natural part of decision for surgery. Clinical guidelines on surgical indications have remained stable in the past decades; however, these recommendations are not based on randomized data and at the moment we are putting very sick patients with endocarditis through high-risk procedures without the proper knowledge and perhaps we refrain from surgery where benefit may be likely.
Eligible patients for study inclusion (inclusion criteria are met), will be assessed at the respective departments in Denmark where IE patients are treated (or in similar department for the international centers). All departments refer to a local endocarditis heart team at a tertiary center with cardiothoracic surgical capabilities. If no exclusion criteria exist (confirmed by the local endocarditis heart team) and the patients sign informed consent after a decent time for reflection (24 hours) then randomization will be done as soon as possible. Study participants with IE are randomized to either:
- Medical Therapy and surgery: Standard of care treatment with antibiotics according to national and international guidelines depending on the microbiological agent and the investigators aim to perform surgery within 48 hours of randomization.
- Medical Therapy alone with standard of care treatment with antibiotics according to guidelines depending on the microbiological agent.
Point of randomization will be in the hospital when the patient is assessed for open heart valve surgery by the heart team.
If study participants are included in the study and are randomized to the medical treatment arm of the trial, participants will stay at the local IE center and continue treatment there. If participants are randomized to surgery, the participants will be transferred to a tertiary center as soon as possible and returned to the non-surgical center for completement of treatment. After end of treatment all participants will be discharged to routinely follow-up at one- and four-weeks and at three months. Additionally, a 12 months visit will be planned for all study participants.
- Conditions
- Endocarditis Infective
- Being tested
- Heart valve surgery
- Keywords
- Surgery, Medical care
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart valve surgeryProcedure or surgery
Heart valve surgery will be performed as soon as possible and preferably within 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Surgery plus medical therapy | Experimental | Heart valve surgery will be performed as soon as possible and preferably within 48 hours of randomization in addition to standard medical care for IE. Receives: Procedure: Heart valve surgery |
| Medical therapy | No intervention | Only standard medical care for IE. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality (Death) among study participants after randomization
The incidence of all-cause mortality will be compared between treatment groups (medical therapy vs. medical therapy + surgery). [Date on all-mortality will be assessed in the ASTERIx study database REDCap (electronic Case Report File (eCRF)) and all information in the database are gathered from the study participants medical records].
Measured: It will be assessed at discharge, and every year thereafter
Number of study participants with clinical stroke (persisting symptoms >24 hours from onset) after randomization
The incidence of stroke with corresponding clinical signs of stroke (e.g., sudden numbness or weakness of the face, arm or leg, typically in one side of the body, confusion: trouble speaking or understanding speech etc.). [The information on clinical stroke are assessed in the study participants medical records which contains information on imaging modalities and this information are entered in the ASTERIx REDCap database. ]
Measured: It will be assessed at discharge, and every year thereafter
Number of study participants with systemic embolization after randomization
New embolic event (with corresponding symptoms from the affected organ/organs), to one of the following organs:
- Brain
- Kidney
- Spleen
- Eyes or
- Extremities
[Information on embolic events are gathered from study participants medical records which includes imaging modalities e.g., PET-CT. Information on new embolic events will be entered in ASTERIx REDCap database, only date of first embolic event after randomization are entered into REDCap.]
Measured: It will be assessed at discharge, and every year thereafter
Number of study participants with new endocarditis event after randomization
The incidence of new endocarditis event after randomization are defined as followed:
- Relapse of bacteria with the same organism > 7 days after study intervention
- Vegetation enlargement (>50%) or local spreading of infection assessed by echocardiography .
- Re-infection after complete treatment for the initial endocarditis episode.
[All the listed outcomes defining new endocarditis event will be assessed from study participants medical records including information from the Danish Microbiology Database and entered into ASTERIx REDCap database]
Measured: It will be assessed at discharge, and every year thereafter
Number of study participants hospitalized for Heart Failure (HF) after randomization
The incidence of hospitalization for Heart Failure among study participants. [Information are gathered from medical records and entered into ASTERIx REDCap database].
Measured: It will be assessed at discharge, and every year thereafter
Secondary outcomes (7)
Individual components of the primary endpoint at study conclusion
One of the 5 individual components of the composite primary outcome. [Please see detailed description in the description of each individual component of the primary outcome].
Measured: It will be assessed at discharge, and every year thereafter
Number of study participants undergoing unplanned heart valve surgery due to IE after randomization
Incidence of unplanned heart valve surgery due to IE. [Information gathered from medical records and entered into ASTERIx REDCap database].
Measured: It will be assessed at discharge, and every year thereafter
Number of study participants with end-stage renal disease and in need of renal replacement therapy after randomization
Incidence of renal replacement therapy (RRT) among study participants WITHOUT RRT prior to date of randomization. [Information regarding RRT will be gathered from study participants medical records and entered in ASTERIx REDCap database].
Measured: It will be assessed at discharge, and every year thereafter
Number of study participants with either implantation of a Pacemaker or Pacemaker extraction after randomization.
The incidence of pacemaker implantations and extractions among study participants. [Information on Pacemaker implantation or extraction will be gathered from study participants medical records and entered into ASTERIx REDCap database]
Measured: It will be assessed at discharge, and every year thereafter
Cause-specific mortality (Death) among study participants after randomization.
Incidence of cause-specific mortality (See definition below)
Definition of cause-specific mortality:
- Cardiovascular OR
- Non-cardiovascular (infectious, malignancy, other, and unknown)
[Date will gathered from medical records and entered into ASTERIx REDCap database].
Measured: It will be assessed at discharge, and every year thereafter
Number of days in hospital.
Length of stay in hospital among study participants will be defined as:
- From date of admission until date of discharge
- From date of randomization until date of discharge [Date will be gathered from study participants medical records and entered into ASTERIx REDCap date. The actual number of dates will be calculated as followed {date of discharge} - {date of admission/date of randomization}]
Measured: It will be assessed at discharge, and every year thereafter
Clinical status at discharge
Composite outcome measuring the incidence of:
- need for help with daily activities
- use of utilities for walking,
- home help
- discharged to nursing facility or
- disability pension [Date will be gathered from medical records and entered into ASTERIx REDCap database. Information on disability pension will be received through register-linkage].
Measured: It will be assessed at discharge, and every year thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start9 Sep 2021
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocarditis InfectiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 496 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emil Loldrup Fosbol
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev and Gentofte Hospital, Bispebjerg Hospital, Amager Hospital, Nordsjaellands Hospital, Copenhagen University Hospital, Hvidovre
- Responsible party
- Sponsor-investigator, Emil Loldrup Fosbol, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Emil L Fosbol, MD, Ph.D, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061355
- Sponsor's protocol ID
- H-21014406
- Acronym
- ASTERIx
- Status last verified
- Apr 2024
- First submitted
- 8 Sep 2021
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotics Vs Antibiotics and Surgical ThERapy for Infective Endocarditis
- ClinicalTrials.gov ID
- NCT05061355
- Acronym / sponsor ID
- ASTERIx / H-21014406
- Conditions
- Endocarditis Infective
- Keywords
- Surgery, Medical care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 496 participants (estimated)
- Lead sponsor
- Emil Loldrup FosbolUniversity, hospital or other
- Collaborators
- Herlev and Gentofte Hospital, Bispebjerg Hospital, Amager Hospital, Nordsjaellands Hospital, Copenhagen University Hospital, Hvidovre
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 29 Sep 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.
Infective endocarditis (IE) is a deadly disease and the incidence is increasing. An important initial assessment of patients with IE includes whether surgical treatment is indicated; yet, appropriate data to guide this assessment do not exist.
The ASTERIx study will assess whether a surgical approach in addition to medical care for treatment of IE is superior to medical care alone. In total, 496 patients will be included in the study over four years. The study is event-driven and will require at least 240 events. The study will assess the primary composite outcome of death, embolization, relapse of IE, new heart failure or reinfection.
Study participants who survive to discharge will be followed by routine clinical check-ups at one- and four-weeks post-discharge and at three months. Additionally a 12-month study follow-up is planned.
The investigators will also conduct a small substudy to assess the frequency of silent emboli.
Detailed description
Infective endocarditis (IE) is a life-threatening disease and studies suggest that the incidence of IE has almost doubled in the last twenty years. Despite improved disease-management and diagnostics (i.e. antibiotics, surgery, and imaging techniques) IE remains a condition that is hard to diagnose and associated with high mortality (≈1/3 die within one year). Surgery is a key part of the clinical practice in IE, but the role of surgery has been greatly debated and is also used with great variation among centers. Valve repair and replacement are high-risk procedures and per-operative risk is therefore also a natural part of decision for surgery. Clinical guidelines on surgical indications have remained stable in the past decades; however, these recommendations are not based on randomized data and at the moment we are putting very sick patients with endocarditis through high-risk procedures without the proper knowledge and perhaps we refrain from surgery where benefit may be likely.
Eligible patients for study inclusion (inclusion criteria are met), will be assessed at the respective departments in Denmark where IE patients are treated (or in similar department for the international centers). All departments refer to a local endocarditis heart team at a tertiary center with cardiothoracic surgical capabilities. If no exclusion criteria exist (confirmed by the local endocarditis heart team) and the patients sign informed consent after a decent time for reflection (24 hours) then randomization will be done as soon as possible. Study participants with IE are randomized to either:
- Medical Therapy and surgery: Standard of care treatment with antibiotics according to national and international guidelines depending on the microbiological agent and the investigators aim to perform surgery within 48 hours of randomization.
- Medical Therapy alone with standard of care treatment with antibiotics according to guidelines depending on the microbiological agent.
Point of randomization will be in the hospital when the patient is assessed for open heart valve surgery by the heart team.
If study participants are included in the study and are randomized to the medical treatment arm of the trial, participants will stay at the local IE center and continue treatment there. If participants are randomized to surgery, the participants will be transferred to a tertiary center as soon as possible and returned to the non-surgical center for completement of treatment. After end of treatment all participants will be discharged to routinely follow-up at one- and four-weeks and at three months. Additionally, a 12 months visit will be planned for all study participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery plus medical therapy | Experimental | Procedure: Heart valve surgeryHeart valve surgery will be performed as soon as possible and preferably within 48 hours of randomization in addition to standard medical care for IE. |
| Medical therapy | No intervention | –Only standard medical care for IE. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Definite left-sided infective endocarditis defined by the ESC (European Society of Cardiology) modified Duke Criteria
- AND
- Valve vegetation =>10mm AND <=30mm with 1 or no previous embolic event during current IE case
Key exclusion criteria (15 listed)
- Unwilling to sign informed consent
- At least one clear class I recommendation for surgery because of heart failure or uncontrolled local infection (abscess, false aneurysm, fistula)
- Unavailable for follow-up (e.g. tourist)
- OR
- At least one of the following criteria (unsuitable for surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart valve surgeryHeart valve surgery will be performed as soon as possible and preferably within 48 hours | Procedure or surgery | Surgery plus medical therapy |
Primary outcome
All-cause mortality (Death) among study participants after randomization
Time frame: It will be assessed at discharge, and every year thereafter
The incidence of all-cause mortality will be compared between treatment groups (medical therapy vs. medical therapy + surgery). [Date on all-mortality will be assessed in the ASTERIx study database REDCap (electronic Case Report File (eCRF)) and all information in the database are gathered from the study participants medical records].
Number of study participants with clinical stroke (persisting symptoms >24 hours from onset) after randomization
Time frame: It will be assessed at discharge, and every year thereafter
The incidence of stroke with corresponding clinical signs of stroke (e.g., sudden numbness or weakness of the face, arm or leg, typically in one side of the body, confusion: trouble speaking or understanding speech etc.). [The information on clinical stroke are assessed in the study participants medical records which contains information on imaging modalities and this information are entered in the ASTERIx REDCap database. ]
Number of study participants with systemic embolization after randomization
Time frame: It will be assessed at discharge, and every year thereafter
New embolic event (with corresponding symptoms from the affected organ/organs), to one of the following organs: * Brain * Kidney * Spleen * Eyes or * Extremities [Information on embolic events are gathered from study participants medical records which includes imaging modalities e.g., PET-CT. Information on new embolic events will be entered in ASTERIx REDCap database, only date of first embolic event after randomization are entered into REDCap.]
Number of study participants with new endocarditis event after randomization
Time frame: It will be assessed at discharge, and every year thereafter
The incidence of new endocarditis event after randomization are defined as followed: * Relapse of bacteria with the same organism > 7 days after study intervention * Vegetation enlargement (>50%) or local spreading of infection assessed by echocardiography . * Re-infection after complete treatment for the initial endocarditis episode. [All the listed outcomes defining new endocarditis event will be assessed from study participants medical records including information from the Danish Microbiology Database and entered into ASTERIx REDCap database]
Number of study participants hospitalized for Heart Failure (HF) after randomization
Time frame: It will be assessed at discharge, and every year thereafter
The incidence of hospitalization for Heart Failure among study participants. [Information are gathered from medical records and entered into ASTERIx REDCap database].
7 secondary outcomes
Individual components of the primary endpoint at study conclusion
Time frame: It will be assessed at discharge, and every year thereafter
Number of study participants undergoing unplanned heart valve surgery due to IE after randomization
Time frame: It will be assessed at discharge, and every year thereafter
Number of study participants with end-stage renal disease and in need of renal replacement therapy after randomization
Time frame: It will be assessed at discharge, and every year thereafter
Number of study participants with either implantation of a Pacemaker or Pacemaker extraction after randomization.
Time frame: It will be assessed at discharge, and every year thereafter
Cause-specific mortality (Death) among study participants after randomization.
Time frame: It will be assessed at discharge, and every year thereafter
Number of days in hospital.
Time frame: It will be assessed at discharge, and every year thereafter
Clinical status at discharge
Time frame: It will be assessed at discharge, and every year thereafter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Emil L Fosbol, MD, Ph.D principal investigator
Copenhagen University Hospital, Rigshospitalet
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart valve surgery in people with Endocarditis Infective, run by Emil Loldrup Fosbol at 15 sites in 4 countries.
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 3 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Denmark, Netherlands, Sweden, Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emil L Fosbol, MD, Ph.D (+45 354 56340, emil.fosboel@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (Death) among study participants after randomization (time frame: It will be assessed at discharge, and every year thereafter). The study lists 5 primary outcomes in all. 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 14 Nov 2024.