Oritavancin for CIED Infections With MDR Gram-positive Cocci

Launched by MEDICAL UNIVERSITY OF SILESIA · Jun 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different ways of using an antibiotic called oritavancin to treat infections related to cardiac implantable electronic devices (CIED), such as pacemakers or defibrillators. These infections can be caused by drug-resistant bacteria, meaning the usual antibiotics may not work. The trial compares a single dose of oritavancin to the standard treatment of taking another antibiotic, vancomycin, for 7-14 days. It also looks at a different way of giving oritavancin in smaller doses over time, compared to the usual multiple doses of vancomycin for more severe infections.

To participate, you need to be at least 18 years old and have signs of an infection in the area of your device, such as redness, swelling, or pus. You should also have an infection caused by bacteria that are resistant to some treatments. However, if you have a history of allergic reactions to these antibiotics or if your infection is caused by certain other types of bacteria, you would not be eligible. If you join the trial, you’ll receive either oritavancin or vancomycin and be monitored for how well the treatment works and any side effects. It's important to know that this trial is not yet recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Completed 18 years of age
• • 2. 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
• • 3. Probable/ definite diagnosis of right-sided LRIE according to modified Dukes criteria (optional criterion)
• • 4. 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
• • 5. 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:
• • 1. Suspected/confirmed infection with Gram-positive or Gram-negative bacilli or anaerobic bacteria
• • 2. 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)
• • 3. Confirmed resistance of Gram-positive cocci, which are the etiological factor of the infection, to vancomycin and oritavancin.
• • 4. History of hypersensitivity to oritavancin or another lipoglycopeptide antibiotic (applies to the experimental group only)
• • 5. History of hypersensitivity to vancomycin or another glycopeptide antibiotics (applies to the control group only)
• • 6. No possibility of temporarily interrupting/initiating alternative therapy to intravenous infusion of unfractionated heparin
• • 7. Pregnancy or breastfeeding
• • 8. Lack of informed written consent of the patient to participate in the study