NCT03411499

Brief Summary

The purpose of the EARLY study is to evaluate the efficacy and effectiveness of early surgery in patients with Infective Endocarditis (IE).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

December 22, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2020

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

December 22, 2017

Last Update Submit

November 16, 2023

Conditions

Endocarditis

Keywords

AdultEndocarditis/surgeryEmbolism/prevention & controlCardiovascular DiseasesCosts and Cost AnalysisQuality of life

Outcome Measures

Primary Outcomes (1)

  • Stroke-free survival

    Time from randomization until the first occurrence of stroke or death. Stroke is defined as a focal neurologic deficit, lasting at least 24 hours and is categorized as ischemic, hemorrhagic or of uncertain type.

    12 months

Secondary Outcomes (16)

  • Overall survival

    12 months

  • In-hospital mortality

    During follow-up, until discharge from hospital, up to 1 year from randomization date

  • Embolic event during the hospitalization of IE diagnosis

    During follow-up, until discharge from hospital, up to 1 year from randomization date

  • Stroke during the hospitalization of IE diagnosis

    During follow-up, until discharge from hospital, up to 1 year from randomization date

  • Heart failure during the hospitalization of IE diagnosis

    During follow-up, until discharge from hospital, up to 1 year from randomization date

  • +11 more secondary outcomes

Study Arms (2)

Early surgery

EXPERIMENTAL

Surgery within 72 hours from endocarditis diagnosis

Procedure: Early surgery

Conventional therapy

ACTIVE COMPARATOR

Medical treatment and a possible delayed surgical intervention according to the current guidelines

Procedure: Conventional therapy

Interventions

Early surgeryPROCEDURE

Surgery within 72 hours from endocarditis diagnosis

Early surgery
Conventional therapyPROCEDURE

Delayed surgical intervention or medical treatment according to the current guidelines

Conventional therapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Left-sided Infective Endocarditis (IE) according to modified Duke criteria, fulfilling at least one of the following features:
  • IE on native or prosthetic valve with severe mitral or aortic valve regurgitation, without heart failure;
  • IE on native or prosthetic valve, during the first week of antibiotic therapy, have very large (15-30 mm) or large (\>10mm), mobile isolated vegetations due to Staphylococcus aureus, Streptococcus bovis, HACEK or Abiotrophia, without any other indication for surgery;
  • IE on native or prosthetic valve with severe valve regurgitation without heart failure and with large vegetations (\> 10 mm) and Euroscore I 5-19;
  • IE on native or prosthetic valve with moderate o moderate-severe valve regurgitation with large vegetations (\> 10 mm)
  • IE on prosthetic valve due to Staphylococcus aureus or gram negative non HACEK microorganisms.
  • Compliance to study treatments
  • Euroscore I \<20
  • Informed consent signature

You may not qualify if:

  • Patients with right-side IE and IE on a cardiac device
  • Patients with IE and:
  • heart failure , refractory pulmonary oedema, cardiogenic shock or untreatable heart failure
  • fistula involving cardiac chambers or pericardium
  • persistent heart failure or unstable echocardiographic signs or poor haemodynamic tolerance
  • uncontrolled local infection (abscess, pseudoaneurism, fistula, increase in size vegetations)
  • fever and positive blood cultures lasting \>7 days
  • fungal IE or other multi-resistant microorganisms
  • large vegetations (\> 10 mm) after embolic event
  • large vegetations (\> 10 mm) and other predictors of complicated course (heart failure, abscess)
  • vegetations \>30 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SC Cardiochirurgia U - AOU Città della Salute e della Scienza di Torino - PO Molinette

Torino, 10126, Italy

Location

Related Links

MeSH Terms

Conditions

EndocarditisEmbolismCardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesEmbolism and ThrombosisVascular Diseases

Study Officials

  • Enrico Cecchi, MD

    Maria Vittoria Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Partially Randomized Preference Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2017

First Posted

January 26, 2018

Study Start

December 22, 2017

Primary Completion

December 14, 2020

Study Completion

December 14, 2020

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)