An interventional study of Administration of a single or repeated dose of a long half-life antibiotic - oritavancin and Administration of a repeated dose of a short half-life antibiotic - vancomycin in Cardiac Implantable Electronic Device Infections, Infective Endocarditis and Multidrug-resistant Bacteria Screening, sponsored by Medical University of Silesia. Not yet recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by Medical University of Silesia · Not applicable, Interventional, and Treatment
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.
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:
Control group - Vancomycin dosage:
Observation:
Observation will include
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.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's planned enrollment of 100 is close to the median of 92 across 86 interventional studies indexed under Endocarditis.
Browse Endocarditis studies →Medical University of Silesia is the lead sponsor of 115 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with CIED infection with MDR Gram-positive cocci treated with a long half-life lipoglycopeptide antibiotic - oritavancin
Drug: Administration of a single or repeated dose of a long half-life antibiotic - oritavancin
Patients with CIED infection with MDR Gram-positive cocci treated with a short half-life glycopeptide antibiotic - vancomycin
Drug: Administration of a repeated dose of a short half-life antibiotic - vancomycin
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).
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).
Co-primary efficacy endpoint - treatment success rate
Treatment success will be defined as obtaining a clinical response and no recurrence of infection at the same site or the site of CIED reimplantation within three months of F/U.
Time frame: 3 months
Co-primary safety endpoint - no treatment-related Serious Adverse Events
Any adverse event classified as grade 3-5 according Health Technology Assessment report developed by the Agency for Health Technology Assessment and Tariff System (Poland) and related to using the investigational product (scores of 3-5) will be counted as a safety endpoint.
Time frame: 3 months
Clinical response rate
Clinical response will be defined as follows: 1. In the case of ABSSSI: a reduction in the size of the inflammatory lesion by at least 20% compared to the baseline after 48-72 hours of antibiotic therapy (in the case of conservative treatment) or the resolution of ABSSSI/complete healing of the surgical wound assessed after 7-10 days. 2. In the case of isolated PI: a resolution of fever and reduction of inflammatory parameters by ≥50% after 72-120 hours of antibiotic therapy and complete healing of the surgical wound assessed after 10-14 days. 3. In the case of PI complicated by LRIE: a reduction of inflammatory parameters by ≥50% after 72-120 hours of antibiotic therapy, negative control blood cultures after 72 hours, and resolution of fever by the 7th day, complete healing of the surgical wound after 10-14 days and resolution and absence of new echocardiographic signs of infection after the end of antibiotic therapy.
Time frame: 3 months
Median time to clinical response
Median time to clinical response defined as above and given in hours or days (as required).
Time frame: 3 months
Recurrent infection rate
Recurrence of infection will be defined as CIED infection occurring within three months of the completion of previous treatment, caused by the persistence of bacteria with the same phenotype in the skin and subcutaneous tissue, the device pocket, intracardiac leads, the right-sided endocardium or tricuspid valve.
Time frame: 3 months
Rehospitalization rate due to recurrent infection
Hospitalization due to recurrent infection will be defined as a hospital stay resulting from the need for repeated antibiotic administration or repeated surgical intervention related to recurrent infection in the form of ABSSSI, PI, or LRIE (as outlined in point 5).
Time frame: 3 months
Proportion of cases in which infection worsened from superficial or local to systemic despite drug therapy
A case in which an infection escalates from superficial or localized to systemic despite receiving drug therapy will be defined as a situation in which, after performing all planned initial tests, including transesophageal echocardiography and blood cultures, ABSSSI or PI will be diagnosed. However, during further follow-up, new clinical symptoms, laboratory tests, or imaging studies will indicate the development of LRIE.
Time frame: 3 months
Proportion of cases in which alternative "rescue" antibiotic therapy was used due to treatment failure
Treatment failure was defined as a lack of clinical response or worsening of infection despite adequate antibiotic therapy and surgical treatment (if necessary) or the need for alternative "rescue" antibiotic therapy.
Time frame: 3 months
Plan to share: Yes — The raw IPD data that underlie results in a publications will be openly available.
Supporting information: Study protocol
Time frame: A link to the IPD data that underlie results in a publication will be available immediately after the manuscript is accepted and published.
Access criteria: The raw IPD data and supporting Information will be openly available in the Polish Platform of Medical Research (https://ppm.edu.pl/search/researchdata?ps=20\&t=simple\&showRel=false\&lang=pl\&qp=\&cid=1577414) under the CC BY license.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical University of Silesia →