[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658977":3},{"organization":4,"outcomesModule":7,"designInfo":71,"detailedDescription":70,"studyPopulation":74,"armGroups":75,"interventions":81,"overallOfficials":87,"centralContacts":91,"locations":97,"responsibleParty":124,"collaborators":70,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":128,"sex":134,"minAge":135,"maxAge":70,"enrollmentInfo":136,"targetDuration":70,"studyType":139,"phases":70,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":150,"whyStopped":70,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Kirby Institute","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":70},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","Day 1 through Day 8 visit (Day 8 ±2 days)",{"measure":14,"description":15,"timeFrame":16},"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.","Day 1 through Day 70",[18,22,25,28,32,35,38,42,45,48,51,55,59,63,66],{"measure":19,"description":20,"timeFrame":21},"Measured Dalbavancin Plasma Concentration","Dalbavancin concentration at protocol-specified sampling time points; mg\u002FL;","Day 1-70",{"measure":23,"description":24,"timeFrame":21},"Model-Predicted Dalbavancin Concentration","model-predicted concentrations based on observed concentration-time and covariate data; mg\u002FL",{"measure":26,"description":27,"timeFrame":21},"Estimated Dalbavancin Clearance","Population\u002Findividual PK estimate; L\u002Fhour",{"measure":29,"description":30,"timeFrame":31},"Estimated Dalbavancin Volume of Distribution","population\u002Findividual PK estimate; L;","Day 1 - 70",{"measure":33,"description":34,"timeFrame":21},"Estimated Dalbavancin Half-Life","model-derived half-life; hours;",{"measure":36,"description":37,"timeFrame":21},"PK\u002FPD Target Attainment","proportion of participants achieving the prespecified exposure target; percentage of participants;",{"measure":39,"description":40,"timeFrame":41},"Proportion of Scheduled PK\u002FTDM Samples Collected and Analysable","Number of analysable scheduled samples divided by the number of scheduled samples.\n\nUnit: Percentage of samples.","Day 70",{"measure":43,"description":44,"timeFrame":41},"PK\u002FTDM Assay Turnaround Time","Time between sample collection\u002Freceipt and availability of the assay result, as prespecified in the analysis plan.\n\nUnit: days",{"measure":46,"description":47,"timeFrame":41},"Proportion of Participants With Bayesian Forecasting Completed","Proportion of participants for whom the prespecified retrospective Bayesian forecast can be completed.\n\nUnit: Percentage of participants.",{"measure":49,"description":50,"timeFrame":41},"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\u002Fleast 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.",{"measure":52,"description":53,"timeFrame":54},"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).","Enrolment through Day 70",{"measure":56,"description":57,"timeFrame":58},"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.","Baseline and Day 70",{"measure":60,"description":61,"timeFrame":62},"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.","Day 14 to Day 90 after enrolment",{"measure":64,"description":65,"timeFrame":58},"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\u002Fdiscomfort and anxiety\u002Fdepression 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.",{"measure":67,"description":68,"timeFrame":69},"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.","Through study completion, approximately 3 years",null,{"allocation":70,"interventionModel":70,"interventionModelDescription":70,"primaryPurpose":70,"observationalModel":72,"timePerspective":73,"maskingInfo":70},"COHORT","PROSPECTIVE","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.",[76],{"label":77,"type":70,"description":78,"interventionNames":79},"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.",[80],"Drug: dalbavancin",[82],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":70},"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.",[77],[88],{"name":89,"affiliation":5,"role":90},"Marianne Martinello, A Prof","PRINCIPAL_INVESTIGATOR",[92],{"name":93,"role":94,"phone":95,"phoneExt":70,"email":96},"Hila Haskelberg","CONTACT","0293850900","hhaskelberg@kirby.unsw.edu.au",[98,113],{"facility":99,"status":70,"city":100,"state":101,"zip":70,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"Prince of Wales Hospital","Sydney","New South Wales","Australia","AU",{"type":105,"coordinates":106},"Point",[107,108],151.20732,-33.86785,{"lat":108,"lon":107},[111],{"name":89,"role":94,"phone":95,"phoneExt":70,"email":112},"mmartinello@kirby.unsw.edu.au",{"facility":114,"status":70,"city":100,"state":101,"zip":70,"country":102,"countryCode":103,"cosmosGeoPoint":115,"geoPoint":117,"contacts":118},"St Vincent's Hospital Sydney",{"type":105,"coordinates":116},[107,108],{"lat":108,"lon":107},[119,122],{"name":120,"role":94,"phone":95,"phoneExt":70,"email":121},"Gail Matthews, Prof","Gmatthews@kirby.unsw.edu.au",{"name":123,"role":94,"phone":70,"phoneExt":70,"email":70},"David Goodman, Dr",{"type":125,"investigatorFullName":70,"investigatorTitle":70,"investigatorAffiliation":70,"oldNameTitle":70,"oldOrganization":70},"SPONSOR","100658977","optimised-dalbavancin-dosing-for-serious-gram-positive-bacterial-infections-100658977",false,"NCT07858526","Optimised Dalbavancin Dosing for Serious Gram-Positive Bacterial Infections","EDGAR: A Multicentre Prospective Observational Study Evaluating Dalbavancin Pharmacokinetics, Therapeutic Drug Monitoring and Clinical Outcomes in Serious Gram-Positive Bacterial Infections","EDGAR","Inclusion Criteria:\n\n* Age ≥18 years.\n* 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).\n* Receiving alternative effective antibiotic therapy for at least 24 hours and no more than 14 days at screening.\n* Dalbavancin has been prescribed or is planned to be prescribed by the treating clinician as part of routine clinical care.\n* Able to provide written informed consent.\n* Willing and able to participate in study procedures, including follow-up visits and drug monitoring.\n\nExclusion Criteria:\n\n* History of severe allergic reaction or hypersensitivity to dalbavancin or any of its components.\n* Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²) or currently receiving dialysis.\n* Decompensated liver disease (Child-Pugh class B or C).\n* Culture-negative infection.\n* Any other active infection requiring concurrent antibiotic treatment that could interfere with study outcomes.\n* Infection caused by a gram-positive organism unlikely to be susceptible to dalbavancin, including Staphylococcus aureus with vancomycin MIC \\>2 μg\u002FmL or vanA vancomycin-resistant Enterococcus spp.\n* Participation in another interventional clinical trial that may confound study outcomes.\n* 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.\n* 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).","ALL","18 Years",{"count":137,"type":138},50,"ESTIMATED","OBSERVATIONAL","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.\n\nEDGAR 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.\n\nEDGAR will collect scheduled pharmacokinetic and therapeutic drug monitoring (PK\u002FTDM) 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.",[142],"Serious Gram-Positive Bacterial Infections",[144,145,146,147,148,149],"Dalbavancin","Therapeutic Drug Monitoring","Pharmacokinetics","Long-Acting Antibiotic","Gram-Positive Infection","Serious Bacterial Infection","NOT_YET_RECRUITING","2026-09-30",{"date":153,"type":154},"2026-10-05","ACTUAL",{"date":156,"type":138},"2027-01-01",{"date":158,"type":138},"2029-12-31",{"name":5,"class":6},2]