Oritavancin for Treatment of Serious Cardiac Infections (NCT07550595) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Oritavancin for Treatment of Serious Cardiac Infections
Australia20 participantsStarted 2026-07-01
Plain-language summary
Cardiac infections, including infective endocarditis and cardiovascular implantable electronic device infections, are associated with substantial morbidity and mortality and are commonly caused by gram-positive bacteria. Standard management typically requires prolonged courses of intravenous antibiotics and extended hospitalisation, which are costly, burdensome, and associated with complications related to long-term vascular access. People who inject drugs are disproportionately affected and often experience stigma, barriers to care, and poorer outcomes. Long-acting lipoglycopeptides such as oritavancin maintain therapeutic serum concentrations for prolonged periods and may offer an alternative to conventional intravenous antibiotic regimens. Oritavancin is not TGA-registered in Australia and is accessed as an unregistered medicine (for example, via SAS or clinical trials). It is approved in other jurisdictions, including the United States and European Union, for acute bacterial skin and skin structure infections. Prospective data in cardiac infections remain limited, and optimal dosing strategies, including the role of therapeutic drug monitoring, are uncertain. This multicentre, open-label pilot study will assess the feasibility, pharmacokinetics, safety, acceptability, and preliminary efficacy of oritavancin for gram-positive cardiac infections using both standard fixed dosing and TDM-guided dosing strategies. Findings will inform PK/PD modelling, the potential role of TDM, and the design of future larger-scale trials and models of care, including alternatives to prolonged inpatient intravenous therapy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥18 years
✓. Hospitalised for management of a cardiac infection (infective endocarditis or cardiovascular implantable electronic device infections)
✓. Gram-positive organism identified in blood or tissue culture, that in the opinion of the investigator is the cause of cardiac infection and would be treatable with a finite antibiotic duration (e.g., 4-6 weeks)
✓. Afebrile for at least 24 hours at screening
✓. Clearance of blood cultures for at least 24 hours at screening
✓. Receiving effective antibiotic therapy for at least 24 hours and no more than 14 days at screening
✓. Willingness of both treating provider and participant to proceed with oritavancin therapy
✓. Able to provide written informed consent
Exclusion criteria
✕. History of severe allergic reaction or hypersensitivity to oritavancin or any of its components
✕. Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) or currently receiving dialysis
✕. Severe hepatic impairment (Child-Pugh class C)
✕. Current infection involving the central nervous system, including septic emboli, ischemic or haemorrhagic stroke, epidural abscess, or meningitis (excluding prior/unrelated central nervous system events).
✕. Presence of prosthetic heart valve
✕. Culture negative endocarditis
✕. Presence of any other active infection requiring concurrent antibiotic treatment that could interfere with study outcomes
✕. Infection with Gram positive organism not susceptible to oritavancin or vancomycin (vancomycin MIC \> 2 μg/mL).