NCT03148756终止2 期
Phase 2, Open-Label, Randomized, Multicenter Study to Compare the Efficacy and Safety of Dalbavancin to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Documented Infective Endocarditis
AbbVie1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2017年5月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population
研究概览
简要总结
This study will compare dalbavancin to standard of care (SOC) antibiotic therapy for the completion of therapy in patients with complicated bacteremia or infective endocarditis.
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
- Single (Outcomes Assessor)
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
- •A diagnosis of complicated bacteremia or infective endocarditis
- •Gram-positive bacteremia at screening with methicillin-susceptible Staphylococcus aureus (MSSA), methicillin-resistant Staphylococcus aureus (MRSA) or Streptococci
- •Treatment with standard of care antibiotics for 72 hours (h) - 10 days
- •Defervescence for at least 24h and clearance of bacteremia from screening pathogen.
排除标准
- •Embolic events
- •History of prosthetic valve surgery, cardiac device or prosthetic joint
- •Left-sided endocarditis due to Staphylococcus aureus (S. aureus)
- •Large mobile vegetations (>10 mm) on mitral valves
- •Perivalvular abscess
- •Uncomplicated bacteremia due to S. aureus
- •Gram-negative bacteria or fungi in blood cultures
- •Heart failure associated with infective endocarditis [Left Ventricular Ejection Fraction (LVEF) <40%]
- •Intravascular material or removable infection source not intended to be removed within 4 days postrandomization
- •Planned valve replacement surgery within 3 days of randomization
- •Refractory shock, significant hepatic insufficiency or severe leukopenia [Absolute Neutrophil Count (ANC) < 500 cells/mm^3]
- •Known osteomyelitis
- •Hypersensitivity to dalbavancin or other drugs in glycopeptide class
- •Infection with enterococci, coagulase-negative staphylococci, or with organism not susceptible to dalbavancin or vancomycin
- •Immunosuppression/immune deficiency
- •Concomitant systemic antibacterial therapy for gram-positive infection other than that allowed in protocol
- •Pregnant or nursing females.
研究组 & 干预措施
Dalbavancin
Experimental
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
干预措施: Dalbavancin (Drug)
Standard of Care
Active Comparator
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
干预措施: Standard of Care (Drug)
结局指标
主要结局
Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population
时间窗: Day 84
Clinical response was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. Failure was defined as: ongoing signs and symptoms considered by the investigator to be related to complicated bacteremia or IE requiring additional antibacterial therapy or unplanned valve replacement, recurrent bacteremia, death during the study period up to Day 84 or discontinuation of the study medication due to an adverse event.
次要结局
- Number of Participants With Day 84 Mortality in the Safety Population(Day 84)
- Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population(Day 42)
- Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population(Day 42)
- Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population(Day 42)
- Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the CE Population(Day 84)
- Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population(Day 42)
- Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population(Day 84)
- Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population(Day 84)
- Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population(Day 84)
- Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population(Day 42)
- Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the ITT Population(Day 84)
- Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the CE Population(Day 42)
研究者
研究点 (1)
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