Antibiotics Vs Antibiotics and Surgical ThERapy for Infective Endocarditis

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 84
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Aarhus University Hospital
RECRUITING
Aarhus
Amager Hvidovre Hospital
RECRUITING
Copenhagen
Bispebjerg Hospital
RECRUITING
Copenhagen
University Hospital of Copenhagen, Rigshospitalet
RECRUITING
Copenhagen
Herlev and Gentofte Hospital
RECRUITING
Gentofte Municipality
Nordsjællands Hospital
RECRUITING
Hillerød
Odense University Hospital
RECRUITING
Odense
Zealand University Hospital
RECRUITING
Roskilde
Germany
Leipzig Heart Center
RECRUITING
Leipzig
Netherlands
Amsterdam University Medical Center
RECRUITING
Amsterdam
Catharina Hospital
RECRUITING
Eindhoven
Leiden University Medical Center
RECRUITING
Leiden
Sweden
Linköping Heart Center, University Hospital
RECRUITING
Linköping
Karolinska Institutet
RECRUITING
Stockholm
Contact Information
Primary
Emil L Fosbol, MD, Ph.D
emil.fosboel@regionh.dk
+45 354 56340
Backup
Peter L Graversen, MD
peter.laursen.graversen@regionh.dk
+45 354 58698
Time Frame
Start Date: 2021-09-09
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 496
Treatments
Experimental: 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.
No_intervention: Medical therapy
Only standard medical care for IE.
Sponsors
Collaborators: Bispebjerg Hospital, Nordsjaellands Hospital, Herlev and Gentofte Hospital, Copenhagen University Hospital, Hvidovre, Amager Hospital
Leads: Emil Loldrup Fosbol

This content was sourced from clinicaltrials.gov