Oritavancin for CIED Infections With MDR Gram-positive Cocci (NCT07013552) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Oritavancin for CIED Infections With MDR Gram-positive Cocci
Poland100 participantsStarted 2025-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Completed 18 years of age
✓. Presence of signs and symptoms of superficial ABSSSI or PI in the form of a) redness/warmth/swelling/pain 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/erosion of the device pocket, with purulent discharge from the wound or discharge giving a positive microbial culture
✓. Probable/ definite diagnosis of right-sided LRIE according to modified Dukes criteria (optional criterion)
✓. Suspected/confirmed 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
✓. Suspected/confirmed 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.
Exclusion criteria
✕. Suspected/confirmed infection with Gram-positive or Gram-negative bacilli or anaerobic bacteria
✕. Suspected/confirmed 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)
✕. Confirmed resistance of Gram-positive cocci, which are the etiological factor of the infection, to vancomycin and oritavancin.
✕. History of hypersensitivity to oritavancin or another lipoglycopeptide antibiotic (applies to the experimental group only)
✕. History of hypersensitivity to vancomycin or another glycopeptide antibiotics (applies to the control group only)
✕. No possibility of temporarily interrupting/initiating alternative therapy to intravenous infusion of unfractionated heparin
✕. Pregnancy or breastfeeding
✕. Lack of informed written consent of the patient to participate in the study