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Optimised Dalbavancin Dosing for Serious Gram-Positive Bacterial Infections

ConditionSerious Gram-Positive Bacterial Infections
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKirby Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Adults aged 18 years or older who are hospitalised at participating Australian hospitals with a serious gram-positive bacterial infection and for whom dalbavancin has been prescribed or is planned to be prescribed by the treating clinician as part of routine clinical care. Eligible infections may include bloodstream infection, infective endocarditis, cardiovascular implantable electronic device infection, bone or joint infection, other prosthetic or device-associated infection, deep-seated abscess, or severe soft-tissue infection.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • dalbavancin

    Drug

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Participants Receiving Dalbavancin as Part of Routine Clinical Care1 intervention

Trial outcomes

Primary outcomes

1

Proportion of Participants Completing Protocol-Specified Pharmacokinetic Sampling Associated With Clinically Administered Dalbavancin Doses

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.

Time frame
Day 1 through Day 8 visit (Day 8 ±2 days)
2

Proportion of Participants With Pharmacokinetically Evaluable Data for External Model Validation

Proportion of enrolled participants with concentration-time and covariate data sufficient for external evaluation of at least one prespecified published dalbavancin population pharmacokinetic model.

Time frame
Day 1 through Day 70

Secondary outcomes

1

Measured Dalbavancin Plasma Concentration

Dalbavancin concentration at protocol-specified sampling time points; mg/L;

Time frame
Day 1-70
2

Model-Predicted Dalbavancin Concentration

model-predicted concentrations based on observed concentration-time and covariate data; mg/L

Time frame
Day 1-70
3

Estimated Dalbavancin Clearance

Population/individual PK estimate; L/hour

Time frame
Day 1-70
4

Estimated Dalbavancin Volume of Distribution

population/individual PK estimate; L;

Time frame
Day 1 - 70

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kirby Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: