Oral Antibiotics for Infective Endocarditis
Trial Summary
What is the purpose of this trial?
Infective endocarditis (IE) is a serious infection associated with significant morbidity and mortality. Recent studies demonstrated an increased risk of infective endocarditis in people who inject drugs (PWIDs). PWIDs have a high rate of non-compliance with hospital admissions and leaving against medical advice. A recent landmark randomized controlled trial demonstrated similar outcomes when comparing partial oral antimicrobial therapy to continued intravenous antimicrobial therapy in the general population. Performing a trial to explore the non-inferiority of oral compared to intravenous antimicrobial therapy in PWIDs is essential in advancing patient care in this high risk increasing population.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the oral antibiotic treatment for infective endocarditis?
Research shows that oral antibiotic treatment for infective endocarditis is as effective as intravenous treatment in certain patients, especially those who are stabilized. This has been demonstrated in studies like the POET trial, which found that oral step-down therapy worked just as well as continuing with intravenous antibiotics.12345
Is partial oral antibiotic therapy safe for treating infective endocarditis?
How is partial oral antibiotic therapy different from other treatments for infective endocarditis?
Partial oral antibiotic therapy for infective endocarditis is unique because it allows patients to switch from intravenous (IV) antibiotics to oral antibiotics after initial treatment, which can be more convenient and less invasive. This approach is particularly considered for select patients and is not yet well established, especially in those who inject drugs.13578
Research Team
Michael Silverman, MD,FRCP
Principal Investigator
LHSC
Eligibility Criteria
This trial is for adults over 18 who inject drugs and have infective endocarditis, a serious heart infection. They must have used IV drugs recently, started IV antibiotics in the hospital for at least 10 days, and need at least two weeks more treatment. People with undrained abscesses around the heart or those not responding to initial treatment can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either continued intravenous antimicrobial therapy or switch to oral antimicrobial therapy after at least 10 days of IV therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a transthoracic echocardiogram within 72 hours of stopping therapy
Treatment Details
Interventions
- Partial oral antimicrobial therapy
Partial oral antimicrobial therapy is already approved in European Union, United States for the following indications:
- Infective endocarditis
- Bone and joint infections
- Uncomplicated bloodstream infections
- Infective endocarditis
- Bone and joint infections
- Uncomplicated bloodstream infections
Find a Clinic Near You
Who Is Running the Clinical Trial?
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre OR Lawson Research Institute of St. Joseph's
Lead Sponsor
Lawson Health Research Institute
Lead Sponsor