Actively Recruiting
Antibiotics Vs Antibiotics and Surgical ThERapy for Infective Endocarditis
Led by Emil Loldrup Fosbol · Updated on 2024-11-14
496
Participants Needed
15
Research Sites
246 weeks
Total Duration
On this page
Sponsors
E
Emil Loldrup Fosbol
Lead Sponsor
H
Herlev and Gentofte Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Antibiotics Vs Antibiotics and Surgical ThERapy for Infective Endocarditis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Definite left-sided infective endocarditis defined by the ESC modified Duke Criteria
- Valve vegetation size between 10mm and 30mm with one or no previous embolic event during the current IE case
You will not qualify if you...
- Unwilling to sign informed consent
- Clear class I recommendation for surgery due to heart failure or uncontrolled local infection
- Unavailable for follow-up (e.g., tourist)
- Intracranial hemorrhage within the past month
- Life expectancy less than 1 year
- Age 85 years or older
- Body mass index below 15 or above 45
- Possible severe liver cirrhosis (Child-Pugh Class B or worse)
- Clinical frailty score of 5 or above
- EUROSCORE II greater than 50%
- Severe pulmonary disease (FEV1 or DLCO less than 30% of expected)
- Left ventricular ejection fraction less than 20%
- Technically inoperable (e.g., extracorporeal circulation impossible)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 15 locations
1
Aalborg University Hospital
Aalborg, Denmark
Actively Recruiting
2
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
3
University Hospital of Copenhagen, Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
4
Amager Hvidovre Hospital
Copenhagen, Denmark
Actively Recruiting
5
Bispebjerg Hospital
Copenhagen, Denmark
Actively Recruiting
6
Herlev and Gentofte Hospital
Gentofte Municipality, Denmark
Actively Recruiting
7
Nordsjællands Hospital
Hillerød, Denmark
Actively Recruiting
8
Odense University Hospital
Odense, Denmark
Actively Recruiting
9
Zealand University Hospital
Roskilde, Denmark
Actively Recruiting
10
Leipzig Heart Center
Leipzig, Germany, 04289
Actively Recruiting
11
Amsterdam University Medical Center
Amsterdam, Netherlands, 1105
Actively Recruiting
12
Catharina Hospital
Eindhoven, Netherlands, 5623
Actively Recruiting
13
Leiden University Medical Center
Leiden, Netherlands
Actively Recruiting
14
Karolinska Institutet
Stockholm, Solna, Sweden, 17177
Actively Recruiting
15
Linköping Heart Center, University Hospital
Linköping, Sweden, 581 85
Actively Recruiting
Research Team
E
Emil L Fosbol, MD, Ph.D
CONTACT
P
Peter L Graversen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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