Oritavancin for CIED Infections With MDR Gram-positive Cocci

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.

Conditions

• Cardiac Implantable Electronic Device Infections
• Infective Endocarditis
• Multidrug-resistant Bacteria Screening
• Gram Positive Bacterial Infection
• Antibiotic Resistant Strain
• Antibiotic Therapy
• Healthcare Associated Infections

Interventions

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. In superficial ABSSSI or PI: Single dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion in 5% glucose solution. In 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).

DRUG

Administration of a repeated dose of a short half-life antibiotic - vancomycin

Intravenous administration of repeated doses of glycopeptide antibiotic - vancomycin. Repeated doses of 15-20 mg/kg 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).

Sponsors & Collaborators

• Medical Research Agency, Poland

  collaborator OTHER_GOV

• Medical University of Silesia

  lead OTHER

Principal Investigators

• Beata Sarecka-Hujar, Professor · Department of Basic Biomedical Science, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia, Poland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-30

Primary Completion

2026-07-31

Completion

2026-10-31

Countries

• Poland

Study Locations