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NOT YET RECRUITING
NCT07858526

Optimised Dalbavancin Dosing for Serious Gram-Positive Bacterial Infections

Sponsor: Kirby Institute

View on ClinicalTrials.gov

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.

Official title: EDGAR: A Multicentre Prospective Observational Study Evaluating Dalbavancin Pharmacokinetics, Therapeutic Drug Monitoring and Clinical Outcomes in Serious Gram-Positive Bacterial Infections

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2027-01-01

Completion Date

2029-12-31

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

DRUG

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.

Locations (2)

Prince of Wales Hospital

Sydney, New South Wales, Australia

St Vincent's Hospital Sydney

Sydney, New South Wales, Australia