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Antibiotics Vs Antibiotics and Surgical ThERapy for Infective Endocarditis

NCT05061355 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 496

Last updated 2024-11-14

No results posted yet for this study

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.

Conditions

  • Endocarditis Infective

Interventions

PROCEDURE

Heart valve surgery

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

Sponsors & Collaborators

  • Herlev and Gentofte Hospital

    collaborator OTHER

  • Bispebjerg Hospital

    collaborator OTHER

  • Amager Hospital

    collaborator OTHER

  • Nordsjaellands Hospital

    collaborator OTHER

  • Copenhagen University Hospital, Hvidovre

    collaborator OTHER

  • Emil Loldrup Fosbol

    lead OTHER

Principal Investigators

  • Emil L Fosbol, MD, Ph.D · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-09
Primary Completion
2026-06-01
Completion
2026-06-01

Countries

  • Denmark
  • Germany
  • Netherlands
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05061355 on ClinicalTrials.gov