Oritavancin as a Therapeutic Regimen for Cardiac Implantable Electronic Devices Infections With Multidrug-resistant Gram-positive Cocci
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Co-primary efficacy endpoint - treatment success rate
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed 18 years of age
- •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
- •Probable/ definite diagnosis of right-sided LRIE according to modified Dukes criteria (optional criterion)
- •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
- •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.
排除标准
- •Suspected/confirmed infection with Gram-positive or Gram-negative bacilli or anaerobic bacteria
- •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)
- •Confirmed resistance of Gram-positive cocci, which are the etiological factor of the infection, to vancomycin and oritavancin.
- •History of hypersensitivity to oritavancin or another lipoglycopeptide antibiotic (applies to the experimental group only)
- •History of hypersensitivity to vancomycin or another glycopeptide antibiotics (applies to the control group only)
- •No possibility of temporarily interrupting/initiating alternative therapy to intravenous infusion of unfractionated heparin
- •Pregnancy or breastfeeding
- •Lack of informed written consent of the patient to participate in the study
研究组 & 干预措施
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
干预措施: Administration of a single or repeated dose of a long half-life antibiotic - oritavancin (Drug)
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
干预措施: Administration of a repeated dose of a short half-life antibiotic - vancomycin (Drug)
结局指标
主要结局
Co-primary efficacy endpoint - treatment success rate
时间窗: 3 months
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.
Co-primary safety endpoint - no treatment-related Serious Adverse Events
时间窗: 3 months
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.
次要结局
- Clinical response rate(3 months)
- Median time to clinical response(3 months)
- Recurrent infection rate(3 months)
- Rehospitalization rate due to recurrent infection(3 months)
- Proportion of cases in which infection worsened from superficial or local to systemic despite drug therapy(3 months)
- Proportion of cases in which alternative "rescue" antibiotic therapy was used due to treatment failure(3 months)