[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635277":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":70,"collaborators":24,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":24,"enrollmentInfo":82,"targetDuration":24,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":101,"whyStopped":24,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Kirby Institute","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A1: Oritavancin, guideline-based dosing","EXPERIMENTAL","Participants will receive oritavancin intravenously using a fixed weekly dosing schedule consistent with contemporary guideline-based practice. Intensive pharmacokinetic sampling will be performed to develop a population pharmacokinetic model",[13],"Drug: Oritavancin",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort A2: Oritavancin (TDM-guided dosing)","Participants will receive oritavancin intravenously with subsequent dosing intervals and\u002For additional doses guided by therapeutic drug monitoring and individual pharmacokinetic estimates derived from the population pharmacokinetic model developed in Cohort A1",[13],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Oritavancin","Oritavancin administered by intravenous infusion using a fixed weekly dosing schedule consistent with the protocol-defined guideline-based regimen (1.2 g IV once weekly)",[9],null,{"type":20,"name":21,"description":26,"armGroupLabels":27,"otherNames":24},"Participants will receive an initial oritavancin dose (e.g. 1.2 g IV), with subsequent dosing intervals and\u002For additional doses informed by pre-specified TDM algorithms and individual PK estimates derived from the population model developed in Group B1.",[15],[29],{"name":30,"affiliation":5,"role":31},"Gail Matthews, MBChB MRCP(UK) FRACP PhD FAAHM","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},"Hila Haskelberg","CONTACT","61293850900","hhaskelberg@kirby.unsw.edu.au",[39,55,64],{"facility":40,"status":24,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"St Vincent's Hospital","Sydney","New South Wales","2010","Australia","AU",{"type":47,"coordinates":48},"Point",[49,50],151.20732,-33.86785,{"lat":50,"lon":49},[53],{"name":54,"role":31,"phone":24,"phoneExt":24,"email":24},"David Goodman",{"facility":56,"status":24,"city":41,"state":42,"zip":57,"country":44,"countryCode":45,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},"Prince of Wales Hospital","2031",{"type":47,"coordinates":59},[49,50],{"lat":50,"lon":49},[62],{"name":63,"role":31,"phone":24,"phoneExt":24,"email":24},"Marianne Martinello",{"facility":65,"status":24,"city":41,"state":42,"zip":66,"country":44,"countryCode":45,"cosmosGeoPoint":67,"geoPoint":69,"contacts":24},"Royal Prince Alfred Hospital","2050",{"type":47,"coordinates":68},[49,50],{"lat":50,"lon":49},{"type":71,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100635277","phase-2-oritavancin-for-treatment-of-serious-cardiac-infections-100635277",false,"NCT07550595","Oritavancin for Treatment of Serious Cardiac Infections","A Multicentre Phase II Prospective Pilot Study of Pharmacokinetic- and TDM-guided Oritavancin Dosing Strategies for the Management of Gram-positive Cardiac Infections (the OSCAR Study)","OSCAR","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Hospitalised for management of a cardiac infection (infective endocarditis or cardiovascular implantable electronic device infections)\n3. Gram-positive organism identified in blood or tissue culture, that in the opinion of the investigator is the cause of cardiac infection and would be treatable with a finite antibiotic duration (e.g., 4-6 weeks)\n4. Afebrile for at least 24 hours at screening\n5. Clearance of blood cultures for at least 24 hours at screening\n6. Receiving effective antibiotic therapy for at least 24 hours and no more than 14 days at screening\n7. Willingness of both treating provider and participant to proceed with oritavancin therapy\n8. Able to provide written informed consent\n9. Willingness and ability to participate in study procedures, including follow-up visits and drug monitoring\n\nExclusion Criteria:\n\n1. History of severe allergic reaction or hypersensitivity to oritavancin or any of its components\n2. Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²) or currently receiving dialysis\n3. Severe hepatic impairment (Child-Pugh class C)\n4. Current infection involving the central nervous system, including septic emboli, ischemic or haemorrhagic stroke, epidural abscess, or meningitis (excluding prior\u002Funrelated central nervous system events).\n5. Presence of prosthetic heart valve\n6. Culture negative endocarditis\n7. Presence of any other active infection requiring concurrent antibiotic treatment that could interfere with study outcomes\n8. Infection with Gram positive organism not susceptible to oritavancin or vancomycin (vancomycin MIC \\> 2 μg\u002FmL).\n9. Use of contraindicated medications (see Section 8)\n10. Participation in another interventional clinical trial that may confound study outcomes\n11. Pregnant or breastfeeding people, or those planning to become pregnant during the study period (people of childbearing potential must have a negative pregnancy test during hospitalization and use effective contraception for trial duration and for 3 months after last infusion of study medication).\n12. Immunosuppression (defined as active chemotherapy expected to cause absolute neutrophil count \\\u003C100 cells\u002Fmm3 lasting \\>7 days during the study period, bone marrow transplantation in the preceding 90 days, solid organ transplantation within prior 3 months or receipt of augmented immunosuppression for rejection within 3 months, chronic granulomatous disease, HIV with a CD4 count \\\u003C50 cells\u002Fmm3 based on last known measure).\n13. Any condition (e.g. severe cognitive impairment, psychiatric illness, active withdrawal) that, in the opinion of the investigator, would limit the participant's ability to comply with study procedures or give informed consent\n14. Medically unstable in opinion of treating clinician that would preclude participation\n15. Cases in which the investigator deem curative or finite antibiotic treatment unlikely (e.g., long term indefinite suppressive antibiotics are likely such as retained hardware).","ALL","18 Years",{"count":83,"type":84},20,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","Cardiac infections, including infective endocarditis and cardiovascular implantable electronic device infections, are associated with substantial morbidity and mortality and are commonly caused by gram-positive bacteria. Standard management typically requires prolonged courses of intravenous antibiotics and extended hospitalisation, which are costly, burdensome, and associated with complications related to long-term vascular access. People who inject drugs are disproportionately affected and often experience stigma, barriers to care, and poorer outcomes. Long-acting lipoglycopeptides such as oritavancin maintain therapeutic serum concentrations for prolonged periods and may offer an alternative to conventional intravenous antibiotic regimens. Oritavancin is not TGA-registered in Australia and is accessed as an unregistered medicine (for example, via SAS or clinical trials). It is approved in other jurisdictions, including the United States and European Union, for acute bacterial skin and skin structure infections. Prospective data in cardiac infections remain limited, and optimal dosing strategies, including the role of therapeutic drug monitoring, are uncertain. This multicentre, open-label pilot study will assess the feasibility, pharmacokinetics, safety, acceptability, and preliminary efficacy of oritavancin for gram-positive cardiac infections using both standard fixed dosing and TDM-guided dosing strategies. Findings will inform PK\u002FPD modelling, the potential role of TDM, and the design of future larger-scale trials and models of care, including alternatives to prolonged inpatient intravenous therapy.",[90,91,92],"Infective Endocarditis","Cardiac Device Infection","Gram-positive Bacterial Infections",[21,94,95,96,97,98,99,100],"Long-acting antibiotic","Lipoglycopeptide","Infective endocarditis","Cardiac device infection","Gram-positive infection","Therapeutic drug monitoring","Pharmacokinetics","NOT_YET_RECRUITING","2026-04-23",{"date":104,"type":105},"2026-04-29","ACTUAL",{"date":107,"type":84},"2026-07-01",{"date":109,"type":84},"2028-09-30",{"name":5,"class":6},3]