Using oral antibiotics to treat infective endocarditis in people who inject drugs

Partial Oral Antimicrobial Versus Intravenous Antimicrobial Therapy to Treat Infective Endocarditis in People Who Inject Drugs

This study is testing if taking antibiotics by mouth can work just as well as getting them through an IV for treating heart infections in people who inject drugs.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (Academic / other)
• Locations: 2 sites (London, Ontario and 1 other locations)
• Trial ID: NCT04544306 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of partial oral antimicrobial therapy compared to continued intravenous therapy for treating infective endocarditis in people who inject drugs. Participants will be randomly assigned to receive either oral or intravenous antibiotics after a minimum of 10 days of IV therapy, with their treatment tailored based on the susceptibility of the infecting organisms. Follow-up will include weekly assessments for six weeks and additional evaluations at three months to monitor adherence and health outcomes. The goal is to determine if oral therapy can provide similar results to intravenous therapy in this high-risk population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have self-reported intravenous drug use within the last three months and meet the criteria for infective endocarditis.

Not a fit: Patients with infections not susceptible to the required oral antimicrobial agents or those who do not meet the modified Duke criteria for infective endocarditis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment adherence and outcomes for people who inject drugs suffering from infective endocarditis.

How similar studies have performed: Previous studies have shown success with similar approaches in the general population, indicating potential for this method in the targeted group.

Eligibility criteria

Inclusion Criteria:

1. Adults ≥ 18 years with self-reported intravenous drug use within 3 months of admission
2. Transthoracic and/or transesophageal echocardiogram for IE diagnosis should be done within 48 hours of randomization
3. Patients meet the modified Duke criteria for possible or definite infective endocarditis diagnosis
4. Infection with an organism susceptible to at least two oral antimicrobial agents from different classes. In gram-negative bacterial endocarditis, susceptibility to fluoroquinolones only would be acceptable for inclusion
5. Polymicrobial infections may be enrolled if an acceptable oral regimen can be constructed containing at least 2 agents against each gram-positive organism and one against each gram-negative
6. Fungal Endocarditis may be enrolled if susceptibility to an oral azole is confirmed
7. IE Patients who demonstrate improvement with initial intravenous therapy will be recruited
8. Patients should receive a minimum of 10 days initial IV therapy and should have a minimum of 14 days remaining of their antimicrobial therapy

Exclusion Criteria:

1. Undrained valvular, perivalvular, or cardiac abscess on echocardiogram studies
2. Failure to show improvement to initial intravenous antimicrobial therapy
3. Oral antibiotic malabsorption due to gastrointestinal disorders
4. Acutely intoxicated patients who are not able to provide informed consent

Where this trial is running

London, Ontario and 1 other locations

• University Hospital — London, Ontario, Canada (Recruiting)
• Victoria Hospital — London, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Michael Silverman, MD,FRCP — Lhsc
• Study coordinator: Michael Silverman, MD,FRCP

Conditions Infective Endocarditis; PWID; oral antibiotics; endocarditis