Optimised Dalbavancin Dosing for Serious Gram-Positive Bacterial Infections

NCT07858526 · tracked via the Priya Life Science Australia tracker

Sponsor

Kirby Institute

Phase

Observational

Started

2027-01-01

Last updated

2026-10-05

Condition(s) studied

Serious Gram-Positive Bacterial Infections

Investigational drug(s) / intervention(s)

dalbavancin →

dalbavancin: Dalbavancin is prescribed, supplied and administered as part of routine clinical care independently of EDGAR participation. A commonly used regimen for serious gram-positive infection is 1,500 mg intravenously on Day 1 and Day 8; however, dosing, administration and any additional doses are determined by the treating clinician. EDGAR records clinically administered doses for pharmacokinetic and clinical outcome analyses.

Study summary

Serious infections caused by gram-positive bacteria often require several weeks of antibiotic treatment, which may involve prolonged hospitalisation, intravenous treatment and long-term vascular access. Dalbavancin is a long-acting antibiotic that can be given less frequently than conventional intravenous antibiotics.

EDGAR is a multicentre prospective observational study involving up to 50 adults receiving dalbavancin as part of routine clinical care for serious gram-positive infections. The decision to prescribe dalbavancin, including dose, timing and duration, is made by the treating clinician independently of participation in EDGAR.

EDGAR will collect scheduled pharmacokinetic and therapeutic drug monitoring (PK/TDM) blood samples and clinical, safety and participant-reported outcome data. PK modelling and Bayesian forecasting will be undertaken retrospectively and will not be used to guide treatment during EDGAR. Participants will be followed to Day 180.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age ≥18 years. * Hospitalised for management of a serious gram-positive infection that, in the opinion of the treating clinician, would be treatable with a finite antibiotic duration (e.g., 4-6 weeks). * Receiving alternative effective antibiotic therapy for at least 24 hours and no more than 14 days at screening. * Dalbavancin has been prescribed or is planned to be prescribed by the treating clinician as part of routine clinical care. * Able to provide written informed consent. * Willing and able to participate in study procedures, including follow-up visits and drug monitoring. Exclusion Criteria: * History of severe allergic reaction or hypersensitivity to dalbavancin or any of its components. * Severe renal impairment (eGFR \<30 mL/min/1.73 m²) or currently receiving dialysis. * Decompensated liver disease (Child-Pugh class B or C). * Culture-negative infection. * Any other active infection requiring concurrent antibiotic treatment that could interfere with study outcomes. * Infection caused by a gram-positive organism unlikely to be susceptible to dalbavancin, including Staphylococcus aureus with vancomycin MIC \>2 μg/mL or vanA vancomycin-resistant Enterococcus spp. * Participation in another interventional clinical trial that may confound study outcomes. * Any condition (e.g., severe cognitive impairment or psychiatric illness) that, in the opinion of the investigator, would limit the participant's ability to comply with study procedures or provide informed consent. * Clinical presentation that, in the opinion of the investigator, is unlikely to be suitable for curative or finite antibiotic treatment (e.g., requiring indefinite antibiotic suppression).

Primary outcome measure(s)

Proportion of Participants Completing Protocol-Specified Pharmacokinetic Sampling Associated With Clinically Administered Dalbavancin Doses — Day 1 through Day 8 visit (Day 8 ±2 days)
Proportion of enrolled participants who complete the protocol-specified PK sampling associated with clinically administered dalbavancin doses. Required sampling includes Day 1: 5-30 min and 6-20 h post-dose; Day 8, if clinically dosed: pre-dose and 5-30 min post-dose.
Proportion of Participants With Pharmacokinetically Evaluable Data for External Model Validation — Day 1 through Day 70
Proportion of enrolled participants with concentration-time and covariate data sufficient for external evaluation of at least one prespecified published dalbavancin population pharmacokinetic model.

Trial sites (2)

Facility	City	Region	Status
Prince of Wales Hospital	Sydney	New South Wales
St Vincent's Hospital Sydney	Sydney	New South Wales

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07858526 on ClinicalTrials.gov ↗ ← All trials in Australia