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Optimised Dalbavancin Dosing for Serious Gram-Positive Bacterial Infections

Study acronym: EDGAR
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07858526
Lead Sponsor Kirby Institute
Conditions
(from sponsor)
Serious Gram-Positive Bacterial Infections
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov