Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID05144399

Accelerated Treatment of Endocarditis Comparing Shorter and Standard Antibiotic Durations

Led by Herlev Hospital · Updated on 2024-01-18

475

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a shorter antibiotic treatment for patients with left-sided infectious endocarditis caused by Streptococci, Enterococcus faecalis, or Staphylococcus aureus. The study aims to assess whether reducing the treatment duration, based on individual patient response and clinical data, is as safe and effective as the standard longer treatment. This approach may reduce hospital stays and related risks such as mental strain and loss of function. Participants are randomly assigned to receive either accelerated antibiotic treatment or the standard length of treatment. The accelerated group receives shorter treatment durations tailored to the type of bacteria and disease complexity, ranging from 2 to 4 weeks, with adjustments after cardiac surgery. The standard group follows usual treatment durations of 4 to 6 weeks depending on bacterial type and disease status. This open-label study includes approximately 475 patients. During the study, researchers monitor safety outcomes such as mortality, embolic events, and unplanned heart surgery up to 6 months after randomization. They also assess efficacy by measuring days alive without antibiotic treatment and track secondary outcomes including hospital stay length, treatment costs, catheter complications, and recurrence of infection. Participants undergo regular clinical evaluations, laboratory tests, and follow-up visits to collect these data throughout the study period.

CONDITIONS

Brief Title

Accelerated Treatment of Endocarditis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admitted with left-sided infectious endocarditis meeting Duke criteria
  • Less than 14 days of relevant antibiotic treatment for endocarditis
  • Infection caused by Streptococci, Enterococcus faecalis, or Staphylococcus aureus
  • 18 years of age or older
Not Eligible

You will not qualify if you...

  • Known immune system problems
  • Relapse of endocarditis within the past 6 months
  • Unable to give informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 to 6 weeks depending on treatment group and infection type

Participants receive either accelerated or standard length antibiotic treatment for endocarditis, with duration depending on infection type and complexity.

Weekly visits for up to 6 weeks

Follow-up

Duration - 6 months

Participants are monitored for safety and efficacy outcomes including mortality, embolic episodes, and heart surgery events for 6 months after treatment starts.

Periodic visits during follow-up period

Trial Site Locations

Total: 2 locations

1

Rigshositalet

Copenhagen, Denmark, 2100

Actively Recruiting

2

Herlev Hospital

Herlev, Denmark, 2730

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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