Oritavancin for CIED Infections With MDR Gram-positive Cocci

NANot yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

July 31, 2026

Study Completion Date

October 31, 2026

Conditions
Cardiac Implantable Electronic Device InfectionsInfective EndocarditisMultidrug-resistant Bacteria ScreeningGram Positive Bacterial InfectionAntibiotic Resistant StrainAntibiotic TherapyHealthcare 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)."

Trial Locations (1)

40-635

Department of Electrocardiology and Heart Failure, Medical University of Silesia in Katowice, Katowice

Sponsors
All Listed Sponsors
collaborator

Medical Research Agency, Poland

OTHER_GOV

lead

Medical University of Silesia

OTHER

NCT07013552 - Oritavancin for CIED Infections With MDR Gram-positive Cocci | Biotech Hunter | Biotech Hunter