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RECRUITING
NCT05061355
NA

Antibiotics Vs Antibiotics and Surgical ThERapy for Infective Endocarditis

Sponsor: Emil Loldrup Fosbol

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 84 Years

Study Type

INTERVENTIONAL

Enrollment

496

Start Date

2021-09-09

Completion Date

2026-06-01

Last Updated

2024-11-14

Healthy Volunteers

No

Interventions

PROCEDURE

Heart valve surgery

Heart valve surgery will be performed as soon as possible and preferably within 48 hours

Locations (15)

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