Comparing antibiotics alone to antibiotics with surgery for infective endocarditis
Antibiotics Vs Antibiotics and Surgical ThERapy for Infective Endocarditis
This study is testing if adding surgery to antibiotic treatment helps people with infective endocarditis have better health outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 496 (estimated) |
| Ages | 18 Years to 84 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 15 sites (Aalborg and 14 other locations) |
| Trial ID | NCT05061355 on ClinicalTrials.gov |
What this trial studies
This study aims to determine whether adding surgical treatment to antibiotic therapy improves outcomes for patients with infective endocarditis (IE). It will include 496 patients over four years and assess the primary composite outcome of death, embolization, relapse of IE, new heart failure, or reinfection. Participants will be monitored through routine clinical check-ups after discharge and a 12-month follow-up. The study also includes a substudy to evaluate the occurrence of silent emboli.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with definite left-sided infective endocarditis who meet specific criteria regarding valve vegetation and embolic events.
Not a fit: Patients who are unwilling to sign informed consent or have severe comorbidities that make them unsuitable for surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical evidence to guide treatment decisions for patients with infective endocarditis, potentially improving survival rates.
How similar studies have performed: Other studies have indicated the need for randomized data in surgical approaches for infective endocarditis, making this study a novel and necessary investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: * 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 * 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)
Where this trial is running
Aalborg and 14 other locations
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- University Hospital of Copenhagen, Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Amager Hvidovre Hospital — Copenhagen, Denmark (Recruiting)
- Bispebjerg Hospital — Copenhagen, Denmark (Recruiting)
- Herlev and Gentofte Hospital — Gentofte Municipality, Denmark (Recruiting)
- Nordsjællands Hospital — Hillerød, Denmark (Recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
- Zealand University Hospital — Roskilde, Denmark (Recruiting)
- Leipzig Heart Center — Leipzig, Germany (Recruiting)
- Amsterdam University Medical Center — Amsterdam, Netherlands (Recruiting)
- Catharina Hospital — Eindhoven, Netherlands (Recruiting)
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
- Karolinska Institutet — Stockholm, Solna, Sweden (Recruiting)
- Linköping Heart Center, University Hospital — Linköping, Sweden (Recruiting)
Study contacts
- Principal investigator: Emil L Fosbol, MD, Ph.D — Rigshospitalet, Denmark
- Study coordinator: Emil L Fosbol, MD, Ph.D
- Email: emil.fosboel@regionh.dk
- Phone: +45 354 56340
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.