2026-526149-91-00招募中3 期
Efficacy and safety of Dalbavancin in the treatment of infective Endocarditis caused by gram-positive cocci
Friedrich-Schiller-Universitaet Jena9 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2026年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 166
- 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. 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
研究概览
简要总结
The objective of the study is to determine whether treatment with dalbavancin improves treatment success at day 90 in patients with endocarditis caused by Grampositive cocci, compared with the recommended standard antibiotic therapy (including sequential intravenous-oral therapy).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •Confirmed infective left-sided 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
- •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: a. Postmenopausal (12 months of natural amenorrhea or 6 months of amenorrhea with serum FSH > 40 mIU/mL) b. Postoperative (6 weeks after bilateral oophorectomy with or without hysterectomy) c. 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) d. sexual abstinence e. Vasectomy of the partner
- •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
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. 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
Comparison of the Desirability of Outcome Ranking (DOOR) on Day 90 between patients treated with dalbavancin and those treated with standard therapy. 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
- Health economic parameters at T90 (including length of hospital stay in days; costs of antibiotic therapy; number of days of work disability)
- Neurological outcome (National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) at Day 90 and 1 year
- Health-related quality of life (PROMIS-29 domain-specific T-scores and pain intensity, EQ-5D-5L index and VAS, RNLI total score) at 90 days and 1 year
- Overall mortality at 90 days and 1 year
- Cardiac surgery at 90 days and 1 year
- Infectious complications at 90 days and 1 year
- Embolic event at 90 days and 1 year
- Clinical Frailty Scale at 90 days and 1 year
- Occurrence of treatment-related adverse events (T0 to EOT+14 days)
- Dalbavancin level determination and pharmacokinetic analysis (only patients in the intervention group) T1, T2, T14, and if applicable, T21/28/35
- Microbiome analysis and resistance development (nasopharyngeal and rectal swabs/stool samples) T0, T90, and 1 year
研究者
PD Dr. Stefan Hagel
Scientific
Friedrich-Schiller-Universitaet Jena
研究点 (9)
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