EDGAR: Optimised dalbavancin dosing for serious gram-positive bacteria
Serious infections caused by gram-positive bacteria, including infective endocarditis, bone and joint infections and other deep-seated infections, often require several weeks of intravenous antibiotics. This can mean prolonged hospital stays, frequent outpatient infusions or long-term intravenous access, creating a substantial burden for patients and health services. Dalbavancin is a long-acting antibiotic that can be given much less frequently, but there is limited prospective evidence to guide its dosing and monitoring for these serious infections.
EDGAR is investigating how dalbavancin can be used safely and effectively to treat serious gram-positive bacterial infections. Because dalbavancin remains in the body for a long time, it may provide an alternative to daily intravenous antibiotic treatment for selected patients.
The study will examine how best to dose and monitor dalbavancin, including the use of therapeutic drug monitoring, while also assessing clinical outcomes, safety, patient acceptability and the practicalities of delivering this approach in Australian hospitals.
EDGAR is a multicentre, phase II, open-label pilot study involving up to 50 adults with serious gram-positive infections. Participants will receive dalbavancin intravenously on Day one and Day eight, with additional doses if clinically indicated. Blood samples will be collected to measure dalbavancin concentrations and evaluate pharmacokinetic models and therapeutic drug monitoring. Participants will be followed for clinical outcomes, safety, healthcare use and quality of life through Day 180. An optional qualitative sub-study will also explore patient and clinician experiences of the treatment and monitoring pathway.
As a pilot study, EDGAR will generate prospective data on the feasibility, pharmacokinetics, safety and clinical outcomes of dalbavancin treatment for serious gram-positive infections. The study will evaluate whether existing pharmacokinetic models perform well in an Australian population and how therapeutic drug monitoring could be incorporated into clinical care. It will also provide information about treatment acceptability, healthcare use and the practical barriers and enablers to implementing long-acting antibiotic treatment. These findings will help inform the design of future larger comparative studies.
Long courses of intravenous antibiotics can place a significant burden on patients, hospitals and outpatient services. If long-acting antibiotics such as dalbavancin can be used safely with an effective dosing and monitoring strategy, selected patients may be able to receive treatment with fewer intravenous infusions and less reliance on prolonged vascular access.
EDGAR will provide evidence needed to determine how this approach could be implemented in Australian practice and will help inform future trials evaluating whether long-acting antibiotic strategies can improve patient experience and healthcare delivery.
- St Vincent’s Hospital Sydney
- Prince of Wales Hospital
- UNSW Sydney
Investigator-initiated study supported by the Kirby Institute, UNSW Sydney
