Serious Gram-Positive Bacterial InfectionsEDGARNCT07858526
Optimised Dalbavancin Dosing for Serious Gram-Positive Bacterial Infections
An observational study of Serious Gram-Positive Bacterial Infections, run by Kirby Institute at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Serious Gram-Positive Bacterial Infections
- What is being tested?
- dalbavancin
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 2 sitesAustralia
- Study dates
- 1 Jan 2027to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites
Prince of Wales Hospital
Sydney, New South Wales
Marianne Martinello, A Prof, 0293850900, mmartinello@kirby.unsw.edu.au
St Vincent's Hospital Sydney
Sydney, New South Wales
Gail Matthews, Prof, 0293850900, Gmatthews@kirby.unsw.edu.au
David Goodman, Dr
About this study
Official title: EDGAR: A Multicentre Prospective Observational Study Evaluating Dalbavancin Pharmacokinetics, Therapeutic Drug Monitoring and Clinical Outcomes in Serious Gram-Positive Bacterial Infections
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.
- Being tested
- dalbavancin
- Keywords
- Dalbavancin, Therapeutic Drug Monitoring, Pharmacokinetics, Long-Acting Antibiotic, Gram-Positive Infection, Serious Bacterial Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dalbavancinDrug
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 group | Role | What they receive |
|---|---|---|
| Participants Receiving Dalbavancin as Part of Routine Clinical Care | Adults with serious gram-positive bacterial infections for whom dalbavancin has been prescribed or is planned to be prescribed by the treating clinician as part of routine clinical care. EDGAR does not assign dalbavancin treatment or determine dose, timing or duration. Receives: Drug: dalbavancin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 through Day 8 visit (Day 8 ±2 days)
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.
Measured: Day 1 through Day 70
Secondary outcomes (15)
Measured Dalbavancin Plasma Concentration
Dalbavancin concentration at protocol-specified sampling time points; mg/L;
Measured: Day 1-70
Model-Predicted Dalbavancin Concentration
model-predicted concentrations based on observed concentration-time and covariate data; mg/L
Measured: Day 1-70
Estimated Dalbavancin Clearance
Population/individual PK estimate; L/hour
Measured: Day 1-70
Estimated Dalbavancin Volume of Distribution
population/individual PK estimate; L;
Measured: Day 1 - 70
Estimated Dalbavancin Half-Life
model-derived half-life; hours;
Measured: Day 1-70
PK/PD Target Attainment
proportion of participants achieving the prespecified exposure target; percentage of participants;
Measured: Day 1-70
Proportion of Scheduled PK/TDM Samples Collected and Analysable
Number of analysable scheduled samples divided by the number of scheduled samples.
Unit: Percentage of samples.
Measured: Day 70
PK/TDM Assay Turnaround Time
Time between sample collection/receipt and availability of the assay result, as prespecified in the analysis plan.
Unit: days
Measured: Day 70
Proportion of Participants With Bayesian Forecasting Completed
Proportion of participants for whom the prespecified retrospective Bayesian forecast can be completed.
Unit: Percentage of participants.
Measured: Day 70
Desirability of Outcome Ranking (DOOR) at Day 70
Participants will be classified into ordered categories based on overall clinical benefit and harm at Day 70 (Rank 1 = most desirable; Rank 5 = death/least desirable). Among surviving participants, ranks are determined by the number of the following outcomes experienced: treatment failure, infectious complication, and a serious adverse event or adverse event related to dalbavancin. Participants with none of these outcomes have the most desirable rank and participants who die have the least desirable rank. Change in EQ-5D-5L and EQ-VAS may be used to resolve ties within surviving ranks.
Measured: Day 70
Protocol-Defined Safety Events Through Day 70
Number and proportion of participants experiencing Grade 3 or higher adverse events, serious adverse events, adverse events leading to withholding or discontinuation of dalbavancin, and adverse events of special interest (infusion-related reactions).
Measured: Enrolment through Day 70
Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score at Day 70
The EQ-VAS records the participant's self-rated health on a scale from 0 to 100, where 0 represents the worst health the participant can imagine and 100 represents the best health the participant can imagine. Change from baseline to Day 70 will be reported; a higher score represents better self-rated health.
Measured: Baseline and Day 70
Patient Acceptability and Implementation Themes From the Optional Qualitative Sub-study
Themes derived from semi-structured interviews with EDGAR participants relating to acceptability, feasibility, perceived benefits and harms, treatment burden, barriers, enablers and implementation of the dalbavancin and TDM pathway.
Measured: Day 14 to Day 90 after enrolment
Change From Baseline in EQ-5D-5L Health Utility Index Score at Day 70
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument. Responses across mobility, self-care, usual activities, pain/discomfort and anxiety/depression will be converted to an EQ-5D-5L health utility index score using the prespecified value set. Higher scores indicate better health-related quality of life.
Measured: Baseline and Day 70
Clinician Acceptability and Implementation Themes From the Optional Qualitative Sub-study
Themes derived from semi-structured interviews with clinicians involved in EDGAR delivery relating to decision-making, patient selection, workflow and logistics, monitoring, roles and responsibilities, organisational readiness, barriers, enablers and implementation of the dalbavancin and TDM pathway.
Measured: Through study completion, approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serious Gram-Positive Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marianne Martinello, A Prof, Principal investigator, Kirby Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858526
- Sponsor's protocol ID
- EDGAR
- Acronym
- EDGAR
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to make individual participant data publicly available or routinely share individual participant data with external researchers. Study findings will be reported using aggregated, de-identified data. Any future secondary use or sharing of study data would be subject to appropriate scientific review, ethics approval, participant consent requirements, and applicable institutional and privacy requirements.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EDGAR: A Multicentre Prospective Observational Study Evaluating Dalbavancin Pharmacokinetics, Therapeutic Drug Monitoring and Clinical Outcomes in Serious Gram-Positive Bacterial Infections
- ClinicalTrials.gov ID
- NCT07858526
- Acronym / sponsor ID
- EDGAR / EDGAR
- Keywords
- Dalbavancin, Therapeutic Drug Monitoring, Pharmacokinetics, Long-Acting Antibiotic, Gram-Positive Infection, Serious Bacterial Infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving Dalbavancin as Part of Routine Clinical Care | – | Drug: dalbavancinAdults with serious gram-positive bacterial infections for whom dalbavancin has been prescribed or is planned to be prescribed by the treating clinician as part of routine clinical care. EDGAR does not assign dalbavancin treatment or determine dose, timing or duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dalbavancinDalbavancin 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. | Drug | Participants Receiving Dalbavancin as Part of Routine Clinical Care |
Primary outcome
Proportion of Participants Completing Protocol-Specified Pharmacokinetic Sampling Associated With Clinically Administered Dalbavancin Doses
Time frame: 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
Time frame: 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.
15 secondary outcomes
Measured Dalbavancin Plasma Concentration
Time frame: Day 1-70
Model-Predicted Dalbavancin Concentration
Time frame: Day 1-70
Estimated Dalbavancin Clearance
Time frame: Day 1-70
Estimated Dalbavancin Volume of Distribution
Time frame: Day 1 - 70
Estimated Dalbavancin Half-Life
Time frame: Day 1-70
PK/PD Target Attainment
Time frame: Day 1-70
Proportion of Scheduled PK/TDM Samples Collected and Analysable
Time frame: Day 70
PK/TDM Assay Turnaround Time
Time frame: Day 70
Proportion of Participants With Bayesian Forecasting Completed
Time frame: Day 70
Desirability of Outcome Ranking (DOOR) at Day 70
Time frame: Day 70
Protocol-Defined Safety Events Through Day 70
Time frame: Enrolment through Day 70
Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score at Day 70
Time frame: Baseline and Day 70
Patient Acceptability and Implementation Themes From the Optional Qualitative Sub-study
Time frame: Day 14 to Day 90 after enrolment
Change From Baseline in EQ-5D-5L Health Utility Index Score at Day 70
Time frame: Baseline and Day 70
Clinician Acceptability and Implementation Themes From the Optional Qualitative Sub-study
Time frame: Through study completion, approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. There is currently no plan to make individual participant data publicly available or routinely share individual participant data with external researchers. Study findings will be reported using aggregated, de-identified data. Any future secondary use or sharing of study data would be subject to appropriate scientific review, ethics approval, participant consent requirements, and applicable institutional and privacy requirements.
Related trials for Serious Gram-Positive Bacterial Infections
Not yet recruitingPhase 2
Oritavancin for Treatment of Serious Cardiac Infections
Infective Endocarditis, Cardiac Device Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marianne Martinello, A Prof principal investigator
Kirby Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Serious Gram-Positive Bacterial Infections, run by Kirby Institute at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hila Haskelberg (0293850900, hhaskelberg@kirby.unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Completing Protocol-Specified Pharmacokinetic Sampling Associated With Clinically Administered Dalbavancin Doses (time frame: Day 1 through Day 8 visit (Day 8 ±2 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.