Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07013552

Oritavancin for CIED Infections With MDR Gram-positive Cocci

Sponsor: Medical University of Silesia

View on ClinicalTrials.gov

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.

Official title: Oritavancin as a Therapeutic Regimen for Cardiac Implantable Electronic Devices Infections With Multidrug-resistant Gram-positive Cocci

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-06

Completion Date

2026-10

Last Updated

2025-06-10

Healthy Volunteers

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).

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

Locations (1)

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

Katowice, Silesian Voivodeship, Poland