Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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