Efficacy and Safety of Dalbavancin in the Treatment of Infective Endocarditis Caused by Gram-Positive Cocci
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 184
- 试验地点
- 9
- 主要终点
- Comparison of the Desirability of Outcome Ranking (DOOR) on Day 90 between patients treated with dalbavancin and those treated with standard therapy
研究概览
简要总结
This study compares two treatment strategies for antibiotic therapy in endocarditis. The aim of the study is to determine which treatment is more effective overall and better tolerated by patients.
The first strategy is standard therapy: treatment with proven antibiotics, which are usually administered initially as an intravenous infusion in the hospital and can be switched to oral therapy with tablets later on for suitable patients.
The second strategy is the study treatment with dalbavancin: This is a long-acting antibiotic. It is administered as a single infusion; for longer treatment durations, a second infusion may be necessary 14 days later.
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
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
- •written informed consent
- •Confirmed left-sided infective endocarditis (mitral and/or aortic valve) involving native (NV) or prosthetic (PV) valves caused by Gram-positive cocci (staphylococci, streptococci, or enterococci) that are susceptible to dalbavancin.
排除标准
- •Hemodynamic instability requiring vasopressor therapy within the last 72 hours prior to randomization
- •Body temperature ≥38.0°C within the 72 hours prior to randomization
- •Evidence of pathogen growth in a blood culture within the 72 hours prior to randomization
- •Presence of a cardiac abscess at the time of randomization
- •Presence of a remaining infected cardiovascular implantable electronic device (CIED), an infected intravascular graft, or an infected TAVI prosthesis ("TAVI endocarditis") at the time of randomization
- •Duration of effective intravenous antibiotic therapy for endocarditis of < 7 days prior to randomization
- •Remaining duration of required antibiotic therapy for the treatment of endocarditis is less than 10 days (i.e., remaining treatment duration must be at least 10 days)
- •Hypersensitivity to dalbavancin, vancomycin, teicoplanin, or other components of the investigational drug
- •Participation in another clinical interventional trial under the German Medicines Act (AMG), Medical Devices Regulation (MDR), or Medical Devices Act (MPDG) without prior consultation and approval by the respective sponsors prior to randomization
- •Continuous renal replacement therapy (e.g., CVVHD, CVVHDF)
- •Child B or C liver cirrhosis
- •Palliative care
- •Secondary infections requiring a longer course of antibiotic therapy than that intended for the treatment of endocarditis
- •Oral antibiotic therapy already initiated to treat the current episode of endocarditis
- •Scheduled cardiac surgery after randomization, within the period designated for antibiotic treatment of endocarditis
- •Intraspinal or brain abscess (> 0.5 cm)
- •Pregnant and breastfeeding women
- •Women of childbearing potential, unless the following criteria are met:
- •Postmenopausal (12 months of natural amenorrhea or 6 months of amenorrhea with serum FSH > 40 mIU/mL)
- •Postoperative (6 weeks after bilateral oophorectomy with or without hysterectomy)
- •Regular and correct use of a contraceptive method with a failure rate < 1% per year (considered reliable contraceptive methods include oral hormonal contraception, dermal hormonal contraception, contraceptive patches, long-acting injectable contraceptives, progesterone-releasing implants (Implanon®), intramuscular progesterone, tubal ligation (female sterilization), hormone-releasing intrauterine device ("hormonal IUD"), dual barrier methods)
- •sexual abstinence
- •Vasectomy of the partner
研究组 & 干预措施
intervention group
Dalbavancin 500 mg; intravenous, 30-minute infusion duration per administration
干预措施: Dalbavancin administration (Drug)
control group
Therapy in accordance with the recommendations of the current European Society of Cardiology (ESC) guidelines for the treatment of endocarditis, including oral sequential therapy
干预措施: Standard of Care (Investigator Choice) (Drug)
结局指标
主要结局
Comparison of the Desirability of Outcome Ranking (DOOR) on Day 90 between patients treated with dalbavancin and those treated with standard therapy
时间窗: Day 90
Five possible DOOR ratings are distinguished: * Alive, no events * Alive, one event * Alive, two events * Alive, three events * Death within 90 days Door events include: * Cardiac surgery * Infectious complication * Embolic event
次要结局
- Length of hospital stay (days)(Day 90)
- National Institutes of Health Stroke Scale (NIHSS)(Day 90 and 1 year)
- PROMIS-29 domain-specific T-scores and pain intensity(Day 90 and 1 year)
- Overall mortality(Day 90 and 1 year)
- Cardiac surgery(Day 90 and 1 year)
- Infectious complications(Day 90 and 1 year)
- Embolic event(Day 90 and 1 year)
- Clinical Frailty Scale(Day 90 and 1 year)
- Occurrence of treatment-related adverse events(Baseline to End of Therapy +14 days)
- Dalbavancin Plasma Concentration(Day 1, Day 2, Day 14, and if applicable, Day 2, Day 28, Day 35)
- Microbiome analysis(Baseline, Day 90 and 1 year)
- Cost of antibiotic therapy(Day 90)
- Number of days of work disability(Day 90)
- modified Rankin Scale (mRS)(Day 90 and 1 year)
- EQ-5D-5L index(Day 90 and 1 year)
- Reintegration to Normal Living Index (RNLI)(Day 90 and 1 year)
研究者
Stefan Hagel
Sponsorbevollmächtigter
Jena University Hospital