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Oritavancin for CIED Infections With MDR Gram-positive Cocci

Study acronym: ORI-4-CIEDi
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated June 10, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07013552
Lead Sponsor Medical University of Silesia
Collaborators: Medical Research Agency, Poland
Conditions
(from sponsor)		 Cardiac Implantable Electronic Device Infections, Infective Endocarditis, Multidrug-resistant Bacteria Screening, Gram Positive Bacterial Infection, Antibiotic Resistant Strain, Antibiotic Therapy, Healthcare Associated Infections
Related terms Cross Infection, Endocarditis, Gram-Positive Bacterial Infections
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov