Recruiting

Oral Antimicrobials

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT04544306

Conditions

Infective Endocarditis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Partial oral antimicrobial therapy

Study Details

Brief 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.

Conditions

Infective Endocarditis

Study ID

NCT04544306

Start date

Jun 1, 2021

Status verified date

Feb, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Dec 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Partial oral antimicrobial therapy

Switch intravenous antimicrobial therapy to oral after an initial period of 10 days to oral antimicrobial therapy. Antimicrobial choices will be guided by antimicrobial susceptibilities.

Primary outcome measure

  • The number of eligible participants who are approached for consent to participate will be recorded. [ Time Frame: 18 months ]
  • The percentage who consent for enrollment will be determined as well as the reasons for refusal. [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Sarah Shalhoub, MD

5196466100

Locations

University Hospital

Recruiting

London, Ontario, Canada

Contacts

Principal Investigator:

Michael Silverman, MD,FRCP

Victoria Hospital

Recruiting

London, Ontario, Canada

Contacts

Michael Silverman, MD,FRCP

michael.silverman@sjhc.london.on.ca

Principal Investigator:

Sarah Shalhoub, MD

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Feb 26, 2024

Last verified

Feb, 2024

Keywords

  • PWID
  • oral antibiotics
  • endocarditis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2024-02-26.