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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Adults ≥ 18 years with self-reported intravenous drug use within 3 months of admission

• Transthoracic and/or transesophageal echocardiogram for IE diagnosis should be done within 48 hours of randomization

• Patients meet the modified Duke criteria for possible or definite infective endocarditis diagnosis

• 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

• 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

• Fungal Endocarditis may be enrolled if susceptibility to an oral azole is confirmed

• IE Patients who demonstrate improvement with initial intravenous therapy will be recruited

• Patients should receive a minimum of 10 days initial IV therapy and should have a minimum of 14 days remaining of their antimicrobial therapy

Locations
Other Locations
Canada
University Hospital
RECRUITING
London
Victoria Hospital
RECRUITING
London
Contact Information
Primary
Michael Silverman, MD,FRCP
michael.silverman@sjhc.london.on.ca
5196466100
Backup
Sarah Shalhoub, MD
5196466100
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 50
Treatments
No_intervention: Control arm
Standard of Care (intravenous antimicrobial therapy according to the American Heart Association Guideline 2015)
Experimental: Partial oral treatment arm
The mode of antimicrobial delivery is switched to oral therapy after at least 10 days of IV therapy, guided by antimicrobial susceptibility
Related Therapeutic Areas
Sponsors
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

This content was sourced from clinicaltrials.gov