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NOT YET RECRUITING
NCT07550595
PHASE2

Oritavancin for Treatment of Serious Cardiac Infections

Sponsor: Kirby Institute

View on ClinicalTrials.gov

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.

Official title: A Multicentre Phase II Prospective Pilot Study of Pharmacokinetic- and TDM-guided Oritavancin Dosing Strategies for the Management of Gram-positive Cardiac Infections (the OSCAR Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-07-01

Completion Date

2028-09-30

Last Updated

2026-04-29

Healthy Volunteers

No

Interventions

DRUG

Oritavancin

Oritavancin administered by intravenous infusion using a fixed weekly dosing schedule consistent with the protocol-defined guideline-based regimen (1.2 g IV once weekly)

DRUG

Oritavancin

Participants will receive an initial oritavancin dose (e.g. 1.2 g IV), with subsequent dosing intervals and/or additional doses informed by pre-specified TDM algorithms and individual PK estimates derived from the population model developed in Group B1.

Locations (3)

St Vincent's Hospital

Sydney, New South Wales, Australia

Prince of Wales Hospital

Sydney, New South Wales, Australia

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia