Partial Oral Antimicrobials to Treat Infective Endocarditis in People Who Inject Drugs

Summary

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.

Eligibility

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

Conditions2

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