[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"serious-gram-positive-bacterial-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:serious-gram-positive-bacterial-infections":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":20,"type":21},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.",[25],"Serious Gram-Positive Bacterial Infections",[27,28,29,30,31,32],"Dalbavancin","Therapeutic Drug Monitoring","Pharmacokinetics","Long-Acting Antibiotic","Gram-Positive Infection","Serious Bacterial Infection","NOT_YET_RECRUITING","2026-09-30",{"date":36,"type":37},"2026-10-05","ACTUAL",{"date":39,"type":21},"2027-01-01",{"date":41,"type":21},"2029-12-31",{"name":43,"class":44},"Kirby Institute","OTHER_GOV",2]