Oritavancin for CIED Infections With MDR Gram-positive Cocci
NCT ID: NCT07013552
Last Updated: 2025-06-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-06-30
Study Completion Date
2026-10-31
Brief Summary
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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.
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Detailed Description
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Study Objectives:
This study's purpose is to evaluate the safety and efficacy of two antibiotic dosage regimens in a pilot study of cardiac implantable electronic devices (CIED) infections with multidrug-resistant (MDR) Gram-positive cocci.
Study Design:
This study is a single-center randomized, non-inferiority, control trial comparing the efficacy and safety of two antibiotic dosage regimens with a long-half-life antibiotic (oritavancin, experimental group) vs. standard therapy with a short-half-life antibiotic (vancomycin, control group).
Study Assumptions:
The investigators assumed that the efficacy of oritavancin therapy administered as a single intravenous infusion (for surgical incision site infection or pocket infection) or in fractionated doses administered at seven-day intervals (for lead-related infectious endocarditis) would be non-inferior to the efficacy of standard vancomycin therapy administered daily at 8-12 hour intervals and that there would be no difference in the safety profile between the two therapies.
Patient Population:
Patients aged ≥18 with CIED surgical incision site infection (i.e., superficial acute bacterial skin and skin structure infections, ABSSSI) or deep infections of the generator pocket (PI) complicated or not with lead-related infectious endocarditis (LRIE) (optional) with multidrug-resistant (MDR) Gram-positive cocci.
The planned size of the group in the pilot study is 50-100. The planned recruitment period is 15 months, and the observation period is 3 months.
Once all inclusion criteria and none of the exclusion criteria are met, patients who have given written informed consent to participate in the study will be randomly assigned to the experimental group and the control group to achieve a 1:1 group size ratio.
Intervention:
The diagnostic and surgical approach and the duration of antibiotic treatment will be determined depending on the etiological factor and clinical indications by the consensus of European Heart Rhythm Association and Heart Rhythm Society experts on cardiovascular implantable electronic device lead management and extraction and the European Society of Cardiology guidelines for the treatment of infective endocarditis.
The intervention under investigation (experimental) will be administering a single or repeated dose of oritavancin.
The standard intervention will be administering of repeated doses of vancomycin.
Experimental group - Oritavancin dosage:
1. in superficial ABSSSI: Single dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion in 5% glucose solution (infusion volume: 1,000 ml);
2. in isolated PI: Single dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion in 5% glucose solution (infusion volume: 1,000 ml);
3. in LRIE: First dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion in 5% glucose solution (infusion volume: 1,000 ml), 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 TLE).
Control group - Vancomycin dosage:
1. in superficial ABSSSI: Repeated doses of 15-20 mg/kg body weight every 8-12 hours (maximum 3,000 mg/day for patients with normal renal function) administered as an hourly intravenous infusion in 0.9% sodium chloride solution (infusion volume: 500-1,000 ml), under monitoring the drug concentration in serum, for 7-10 days (calculated from the beginning of antibiotic therapy, not less than seven days from surgical tissue debridement, if required);
2. in isolated PI: Repeated doses of 15-20 mg/kg body weight every 8-12 hours (maximum 3,000 mg/day for patients with normal renal function) administered as an hourly intravenous infusion in 0.9% sodium chloride solution (infusion volume: 500-1,000 ml), under monitoring the drug concentration in serum, for 10-14 days (counted from the day of surgical debridement of the generator pocket and TLE, if possible);
3. in LRIE: Repeated doses of 15-20 mg/kg body weight every 8-12 hours (maximum 3,000 mg/day for patients with normal renal function) administered as an hourly intravenous infusion in 0.9% sodium chloride solution (infusion volume: 500-1,000 ml), under monitoring the drug concentration in serum, to achieve the required pharmacotherapy time of 2-6 weeks (counted from the day of surgical debridement of the incision site and TLE).
Observation:
Observation will include
1. Physical examination with the assessment of the CIED implantation site;
2. Routine laboratory tests, including blood count, C-reactive protein (mg/l), procalcitonin (ng/ml), plasma creatinine (mg/dl);
3. Transthoracic echocardiogram with the assessment of bacterial vegetations;
4. Transesophageal echocardiogram with the assessment of bacterial vegetations, with particular emphasis on the tricuspid valve and CIED leads;
5. PET/CT examination with 18F-FDG or SPECT/CT using radioisotope-labeled leukocytes (depending on clinical indications).
Evaluation will be performed at 72-120 hours of therapy, after 5-7 and 14 days of therapy, and after 1 and 3 months of therapy, with endpoints assessed at 3 months.
Primary endpoints will include a complete cure rate and serious treatment-related adverse events at 3 months of follow-up.
Secondary endpoints will include clinical response rates, worsening or recurrence of infection despite drug therapy (including those resulting in rehospitalization and requiring alternative antibiotic therapy), and time to clinical response.
This study's purpose is to evaluate the safety and efficacy of two antibiotic dosage regimens in a pilot study of cardiac implantable electronic devices (CIED) infections with multidrug-resistant (MDR) Gram-positive cocci.
Study Design:
This study is a single-center randomized, non-inferiority, control trial comparing the efficacy and safety of two antibiotic dosage regimens with a long-half-life antibiotic (oritavancin, experimental group) vs. standard therapy with a short-half-life antibiotic (vancomycin, control group).
Study Assumptions:
The investigators assumed that the efficacy of oritavancin therapy administered as a single intravenous infusion (for surgical incision site infection or pocket infection) or in fractionated doses administered at seven-day intervals (for lead-related infectious endocarditis) would be non-inferior to the efficacy of standard vancomycin therapy administered daily at 8-12 hour intervals and that there would be no difference in the safety profile between the two therapies.
Patient Population:
Patients aged ≥18 with CIED surgical incision site infection (i.e., superficial acute bacterial skin and skin structure infections, ABSSSI) or deep infections of the generator pocket (PI) complicated or not with lead-related infectious endocarditis (LRIE) (optional) with multidrug-resistant (MDR) Gram-positive cocci.
The planned size of the group in the pilot study is 50-100. The planned recruitment period is 15 months, and the observation period is 3 months.
Once all inclusion criteria and none of the exclusion criteria are met, patients who have given written informed consent to participate in the study will be randomly assigned to the experimental group and the control group to achieve a 1:1 group size ratio.
Intervention:
The diagnostic and surgical approach and the duration of antibiotic treatment will be determined depending on the etiological factor and clinical indications by the consensus of European Heart Rhythm Association and Heart Rhythm Society experts on cardiovascular implantable electronic device lead management and extraction and the European Society of Cardiology guidelines for the treatment of infective endocarditis.
The intervention under investigation (experimental) will be administering a single or repeated dose of oritavancin.
The standard intervention will be administering of repeated doses of vancomycin.
Experimental group - Oritavancin dosage:
1. in superficial ABSSSI: Single dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion in 5% glucose solution (infusion volume: 1,000 ml);
2. in isolated PI: Single dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion in 5% glucose solution (infusion volume: 1,000 ml);
3. in LRIE: First dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion in 5% glucose solution (infusion volume: 1,000 ml), 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 TLE).
Control group - Vancomycin dosage:
1. in superficial ABSSSI: Repeated doses of 15-20 mg/kg body weight every 8-12 hours (maximum 3,000 mg/day for patients with normal renal function) administered as an hourly intravenous infusion in 0.9% sodium chloride solution (infusion volume: 500-1,000 ml), under monitoring the drug concentration in serum, for 7-10 days (calculated from the beginning of antibiotic therapy, not less than seven days from surgical tissue debridement, if required);
2. in isolated PI: Repeated doses of 15-20 mg/kg body weight every 8-12 hours (maximum 3,000 mg/day for patients with normal renal function) administered as an hourly intravenous infusion in 0.9% sodium chloride solution (infusion volume: 500-1,000 ml), under monitoring the drug concentration in serum, for 10-14 days (counted from the day of surgical debridement of the generator pocket and TLE, if possible);
3. in LRIE: Repeated doses of 15-20 mg/kg body weight every 8-12 hours (maximum 3,000 mg/day for patients with normal renal function) administered as an hourly intravenous infusion in 0.9% sodium chloride solution (infusion volume: 500-1,000 ml), under monitoring the drug concentration in serum, to achieve the required pharmacotherapy time of 2-6 weeks (counted from the day of surgical debridement of the incision site and TLE).
Observation:
Observation will include
1. Physical examination with the assessment of the CIED implantation site;
2. Routine laboratory tests, including blood count, C-reactive protein (mg/l), procalcitonin (ng/ml), plasma creatinine (mg/dl);
3. Transthoracic echocardiogram with the assessment of bacterial vegetations;
4. Transesophageal echocardiogram with the assessment of bacterial vegetations, with particular emphasis on the tricuspid valve and CIED leads;
5. PET/CT examination with 18F-FDG or SPECT/CT using radioisotope-labeled leukocytes (depending on clinical indications).
Evaluation will be performed at 72-120 hours of therapy, after 5-7 and 14 days of therapy, and after 1 and 3 months of therapy, with endpoints assessed at 3 months.
Primary endpoints will include a complete cure rate and serious treatment-related adverse events at 3 months of follow-up.
Secondary endpoints will include clinical response rates, worsening or recurrence of infection despite drug therapy (including those resulting in rehospitalization and requiring alternative antibiotic therapy), and time to clinical response.
Conditions
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Cardiac Implantable Electronic Device Infections
Infective Endocarditis
Multidrug-resistant Bacteria Screening
Gram Positive Bacterial Infection
Antibiotic Resistant Strain
Antibiotic Therapy
Healthcare Associated Infections
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Patients will be randomized 1:1 to the intervention and control groups.
Experimental group:
Oritavancin dosage in superficial ABSSSI or PI: Single dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion.
Oritavancin dosage in LRIE: First dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion, 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).
Control group:
Vancomycin dosage: Repeated doses of 15-20 mg/kg body weight every 8-12 hours administered as an hourly intravenous infusion for 7-10 days in ABSSSI, for 10-14 days in PI, and for 2-6 weeks in LRIE.
Experimental group:
Oritavancin dosage in superficial ABSSSI or PI: Single dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion.
Oritavancin dosage in LRIE: First dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion, 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).
Control group:
Vancomycin dosage: Repeated doses of 15-20 mg/kg body weight every 8-12 hours administered as an hourly intravenous infusion for 7-10 days in ABSSSI, for 10-14 days in PI, and for 2-6 weeks in LRIE.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
The study will be blinded only at the randomization stage. A different time model for antibiotic dosing does not allow for blinding of the Care Provider and allows the Participant to easily identify the type of antibiotic administered based on the information obtained in the consent form for the study.
Study Groups
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Patients treated with a long half-life antibiotic - oritavancin (Tenkasi)
Patients with CIED infection with MDR Gram-positive cocci treated with a long half-life lipoglycopeptide antibiotic - oritavancin
Group Type
EXPERIMENTAL
Administration of a single or repeated dose of a long half-life antibiotic - oritavancin
Intervention Type
DRUG
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).
Patients treated with a short half-life antibiotic - vancomycin (Vancomycin)
Patients with CIED infection with MDR Gram-positive cocci treated with a short half-life glycopeptide antibiotic - vancomycin
Group Type
ACTIVE_COMPARATOR
Administration of a repeated dose of a short half-life antibiotic - vancomycin
Intervention Type
DRUG
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).
Interventions
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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).
Intervention Type
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).
Intervention Type
DRUG
Eligibility Criteria
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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.
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
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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Medical Research Agency, Poland
OTHER_GOV
Sponsor Role
collaborator
Medical University of Silesia
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Beata Sarecka-Hujar, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Basic Biomedical Science, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia, Poland
Locations
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Department of Electrocardiology and Heart Failure, Medical University of Silesia in Katowice
Katowice, Silesian Voivodeship, Poland
Site Status
Countries
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Poland
Central Contacts
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References
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Polewczyk A, Jachec W, Polewczyk M, Nowosielecka D, Brzozowski W, Kutarski A. Outcomes in patients with definite and possible infective endocarditis related to a cardiac implantable electronic device. Pol Arch Intern Med. 2024 Aug 8;134(7-8):16775. doi: 10.20452/pamw.16775. Epub 2024 Jun 17.
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BACKGROUND
Bongiorni MG, Kennergren C, Butter C, Deharo JC, Kutarski A, Rinaldi CA, Romano SL, Maggioni AP, Andarala M, Auricchio A, Kuck KH, Blomstrom-Lundqvist C; ELECTRa Investigators. The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) Registry of Transvenous Lead Extraction Outcomes. Eur Heart J. 2017 Oct 21;38(40):2995-3005. doi: 10.1093/eurheartj/ehx080.
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Chmielarczyk A, Pomorska-Wesolowska M, Romaniszyn D, Wojkowska-Mach J. Healthcare-Associated Laboratory-Confirmed Bloodstream Infections-Species Diversity and Resistance Mechanisms, a Four-Year Retrospective Laboratory-Based Study in the South of Poland. Int J Environ Res Public Health. 2021 Mar 9;18(5):2785. doi: 10.3390/ijerph18052785.
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Joshi S, Shallal A, Zervos M. Vancomycin-Resistant Enterococci: Epidemiology, Infection Prevention, and Control. Infect Dis Clin North Am. 2021 Dec;35(4):953-968. doi: 10.1016/j.idc.2021.07.002.
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Cerini P, Meduri FR, Tomassetti F, Polidori I, Brugneti M, Nicolai E, Bernardini S, Pieri M, Broccolo F. Trends in Antibiotic Resistance of Nosocomial and Community-Acquired Infections in Italy. Antibiotics (Basel). 2023 Mar 24;12(4):651. doi: 10.3390/antibiotics12040651.
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BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
https://antybiotyki.edu.pl/wp-content/uploads/2020/02/Biuletyn-NPOA-_2_2019.pdf
Lekooporność Streptococcus pneumoniae: częstość występowania, mechanizmy, znaczenie kliniczne. Aktualności Narodowego Programu Ochrony Antybiotyków 2019; 2: 1-9.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206334s003lbl.pdf
Food and Drug Administration Orbactiv
https://www.ema.europa.eu/en/medicines/human/EPAR/orbactiv
European Medicines Agency Orbactiv.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KPOD.07.07-IW.07-0004/24
Identifier Type: -
Identifier Source: org_study_id
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