[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593985":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":44,"responsibleParty":58,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":26,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":89,"overallStatus":96,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Medical University of Silesia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients treated with a long half-life antibiotic - oritavancin (Tenkasi)","EXPERIMENTAL","Patients with CIED infection with MDR Gram-positive cocci treated with a long half-life lipoglycopeptide antibiotic - oritavancin",[13],"Drug: Administration of a single or repeated dose of a long half-life antibiotic - oritavancin",{"label":15,"type":16,"description":17,"interventionNames":18},"Patients treated with a short half-life antibiotic - vancomycin (Vancomycin)","ACTIVE_COMPARATOR","Patients with CIED infection with MDR Gram-positive cocci treated with a short half-life glycopeptide antibiotic - vancomycin",[19],"Drug: Administration of a repeated dose of a short half-life antibiotic - vancomycin",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Administration of a single or repeated dose of a long half-life antibiotic - oritavancin","Intravenous administration of a single or repeated dose of lipoglycopeptide antibiotic - oritavancin.\n\nIn superficial ABSSSI or PI: Single dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion in 5% glucose solution.\n\nIn LRIE: First dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion in 5% glucose solution, subsequent doses of 800 mg (2 vials) administered as a 2-3 hour intravenous infusion at 7-day intervals, to achieve the required duration of drug therapy of 2-6 weeks (counted from the day of transvenous lead extraction).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Administration of a repeated dose of a short half-life antibiotic - vancomycin","Intravenous administration of repeated doses of glycopeptide antibiotic - vancomycin.\n\nRepeated doses of 15-20 mg\u002Fkg body weight every 8-12 hours administered as an hourly intravenous infusion in 0.9% sodium chloride solution, under monitoring the drug concentration in serum, for 7-10 days in ABSSSI, for 10-14 days in PI, and for 2-6 weeks in LRIE (counted from the day of transvenous lead extraction).",[15],[32],{"name":33,"affiliation":34,"role":35},"Beata Sarecka-Hujar, Professor","Department of Basic Biomedical Science, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia, Poland","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Danuta Loboda, MD, PhD","CONTACT","(+48) 32 359-89-90","dloboda@sum.edu.pl",{"name":33,"role":39,"phone":26,"phoneExt":26,"email":43},"bsarecka-hujar@sum.edu.pl",[45],{"facility":46,"status":26,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":26},"Department of Electrocardiology and Heart Failure, Medical University of Silesia in Katowice","Katowice","Silesian Voivodeship","40-635","Poland","PL",{"type":53,"coordinates":54},"Point",[55,56],19.02173,50.2597,{"lat":56,"lon":55},{"type":59,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[61],{"name":62,"class":63},"Medical Research Agency, Poland","OTHER_GOV","100593985","oritavancin-for-cied-infections-with-mdr-gram-positive-cocci-100593985",false,"NCT07013552","Oritavancin for CIED Infections With MDR Gram-positive Cocci","Oritavancin as a Therapeutic Regimen for Cardiac Implantable Electronic Devices Infections With Multidrug-resistant Gram-positive Cocci","ORI-4-CIEDi","Inclusion Criteria:\n\n1. Completed 18 years of age\n2. Presence of signs and symptoms of superficial ABSSSI or PI in the form of a) redness\u002Fwarmth\u002Fswelling\u002Fpain or b) separation of the edges of the surgical incision with signs of inflammation or the need for repeated surgical debridement of the wound or c) the presence of decubitus of the skin and subcutaneous tissue in area of the generator or skin abscess\u002Ferosion of the device pocket, with purulent discharge from the wound or discharge giving a positive microbial culture\n3. Probable\u002F definite diagnosis of right-sided LRIE according to modified Dukes criteria (optional criterion)\n4. Suspected\u002Fconfirmed infection with drug-resistant Gram-positive cocci, i.e., Staphylococcus spp. (Stahphylococcus aureus or coagulase-negative staphylococci), Streptococcus spp. or Enterococcus spp. sensitive to oritavancin\n5. Suspected\u002Fconfirmed infection with Gram-positive cocci, i.e., Staphylococcus spp., Streptococcus spp., Enterococcus spp., sensitive to vancomycin or oritavancin and beta-lactam antibiotics in patients with a history of type I anaphylaxis to penicillin.\n\nExclusion Criteria:\n\n1. Suspected\u002Fconfirmed infection with Gram-positive or Gram-negative bacilli or anaerobic bacteria\n2. Suspected\u002Fconfirmed community-acquired infection or infection with Gram-positive cocci sensitive to betalactam antibiotics, including penicillin, ampicillin, or methicillin, based on empirical data or cultures (does not apply to patients with a history of type I anaphylaxis to penicillin)\n3. Confirmed resistance of Gram-positive cocci, which are the etiological factor of the infection, to vancomycin and oritavancin.\n4. History of hypersensitivity to oritavancin or another lipoglycopeptide antibiotic (applies to the experimental group only)\n5. History of hypersensitivity to vancomycin or another glycopeptide antibiotics (applies to the control group only)\n6. No possibility of temporarily interrupting\u002Finitiating alternative therapy to intravenous infusion of unfractionated heparin\n7. Pregnancy or breastfeeding\n8. Lack of informed written consent of the patient to participate in the study","ALL","18 Years",{"count":75,"type":76},100,"ESTIMATED","INTERVENTIONAL",[79],"NA","The study aimed to conduct a randomized, non-inferiority controlled trial to compare the short- and medium-term efficacy and safety of two antibiotic dosage regimens in cardiac implantable electronic devices (CIED) infections with multidrug-resistant Gram-positive cocci: 1) single-dose therapy with a long-half-life antibiotic (oritavancin) vs. standard 7-14 days of therapy with a short-half-life antibiotic (vancomycin) for CIED surgical incision site or pocket infection; and 2) fractionated therapy with a long-half-life antibiotic (oritavancin) at seven-day intervals compared to standard therapy with a short-half-life antibiotic (vancomycin) fractionated in 2-3 daily doses in cases of lead-related infectious endocarditis.",[82,83,84,85,86,87,88],"Cardiac Implantable Electronic Device Infections","Infective Endocarditis","Multidrug-resistant Bacteria Screening","Gram Positive Bacterial Infection","Antibiotic Resistant Strain","Antibiotic Therapy","Healthcare Associated Infections",[90,91,92,93,94,95],"Cardiac implantable electronic device","Gram-positive cocci","Health-care associated infections","Lead-related infective endocarditis","Multidrug-resistant bacteria","Pocket infection","NOT_YET_RECRUITING","2025-06-02",{"date":99,"type":100},"2025-06-10","ACTUAL",{"date":102,"type":76},"2025-06",{"date":104,"type":76},"2026-10",{"name":5,"class":6},1]