Antibiotics Vs Antibiotics and Surgical ThERapy for Infective Endocarditis
NCT ID: NCT05061355
Last Updated: 2024-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
496 participants
INTERVENTIONAL
2021-09-09
2026-06-01
Brief Summary
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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.
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Detailed Description
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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:
1. 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.
2. 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Surgery plus medical therapy
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.
Heart valve surgery
Heart valve surgery will be performed as soon as possible and preferably within 48 hours
Medical therapy
Only standard medical care for IE.
No interventions assigned to this group
Interventions
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Heart valve surgery
Heart valve surgery will be performed as soon as possible and preferably within 48 hours
Eligibility Criteria
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Inclusion Criteria
AND
Valve vegetation =\>10mm AND \<=30mm with 1 or no previous embolic event during current IE case
Exclusion Criteria
* 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
* 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)
18 Years
84 Years
ALL
No
Sponsors
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Herlev and Gentofte Hospital
OTHER
Bispebjerg Hospital
OTHER
Amager Hospital
OTHER
Nordsjaellands Hospital
OTHER
Copenhagen University Hospital, Hvidovre
OTHER
Emil Loldrup Fosbol
OTHER
Responsible Party
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Emil Loldrup Fosbol
MD, PhD
Principal Investigators
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Emil L Fosbol, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
University Hospital of Copenhagen, Rigshospitalet
Copenhagen, , Denmark
Amager Hvidovre Hospital
Copenhagen, , Denmark
Bispebjerg Hospital
Copenhagen, , Denmark
Herlev and Gentofte Hospital
Gentofte Municipality, , Denmark
Nordsjællands Hospital
Hillerød, , Denmark
Odense University Hospital
Odense, , Denmark
Zealand University Hospital
Roskilde, , Denmark
Leipzig Heart Center
Leipzig, , Germany
Amsterdam University Medical Center
Amsterdam, , Netherlands
Catharina Hospital
Eindhoven, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Karolinska Institutet
Stockholm, Solna, Sweden
Linköping Heart Center, University Hospital
Linköping, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Hanne S Jensen, MD
Role: primary
Jonas Povlsen
Role: primary
Ekim Seven, MD
Role: primary
Nana Køber, MD
Role: primary
Kasper Iversen, MD
Role: primary
Malene Wienberg, MD
Role: primary
Kenneth Pedersen, MD
Role: primary
Niels E Bruun, MD
Role: primary
Role: backup
Michael A Borger
Role: backup
Henneke Gerritsen, Research Nurse/Coordinator Ca
Role: primary
Jasper L Selder, MD
Role: backup
Kayan Lam, MD
Role: backup
Jesper Hjortnaes, MD
Role: primary
Christian Olsson, MD, PhD
Role: backup
Farkas Vánky, MD
Role: backup
Other Identifiers
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H-21014406
Identifier Type: -
Identifier Source: org_study_id
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