Open Label Study to Assess the Efficacy and Safety of Daptomycin in Combination With Anti-Cell Wall Active Therapy in the Treatment of Enterococcal Endocarditis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Participants With Any Grade 3 or 4 Toxicity (DAIDS Scale)
研究概览
简要总结
The aim of this study is to determine the safety and efficacy of daptomycin when used as an adjuvant agent to standard care in the treatment of proven native valve Enterococcal endocarditis. Patients with this disease will be offered the option of receiving daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving. The hypothesis of this study is that daptomycin added to standard therapy for Enterococcal endocarditis is safe and efficacious.
Patients who receive daptomycin + standard therapy will be compared to patients who receive standard therapy alone with respect to the following outcomes:
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Safety.
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The frequency of any Grade 3 or 4 toxicity (DAIDS scale) will be measured.
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The frequency of muscle toxicity or renal toxicity, as determined by predefined criteria.
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Efficacy.
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Clinical efficacy.
- Time to clearance of bacteremia
- Cure at 6 weeks following completion of antibiotic therapy
- Mortality at 6 weeks following completion of antibiotic therapy
- Microbiologic efficacy.
- Peak and trough serum bactericidal titers
- The minimum bactericidal concentration of Enterococci to daptomycin
We expect to enroll 40 patients over 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Age 18 or over
- •Definite Enterococcal endocarditis, as defined by modified Duke criteria
- •Able to complete follow-up 3 and 6 weeks following completion of intravenous antibiotic therapy
排除标准
- •Pregnancy or breast feeding
- •Creatine phosphokinase levels over two times the upper limit of normal
- •Renal insufficiency or dialysis requirement.
- •Presence of chronic indwelling bloodstream catheters or foreign body devices suspected as primary or secondary sites of enterococcal infection unamenable to removal or replacement
- •Inability to discontinue or abstain from use of a HMG CoA reductase inhibitor during the study period.
- •Hypersensitivity to any of the study medications.
- •Any condition that, in the investigator's opinion, may interfere with protocol compliance including, but not limited to, active substance abuse and/or dementia.
- •Prosthetic valve endocarditis
研究组 & 干预措施
Daptomycin adjunctive group
Patients with enterococcal endocarditis who elect to receive daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving
干预措施: Daptomycin (Drug)
结局指标
主要结局
Number of Participants With Any Grade 3 or 4 Toxicity (DAIDS Scale)
时间窗: weekly
Number of Participants any Grade 3 or 4 toxicity (DAIDS scale); please see adverse event table for details
Number of Participants With Muscle Toxicity or Renal Toxicity, as Determined by Predefined Criteria
时间窗: weekly
Number of Participants with creatine kinase elevation \> 3x upper limit of normal or elevations of serum Cr \>= 30% above baseline
次要结局
未报告次要终点
研究者
Rhee, Kyu Y.
Assistant Professor
Weill Medical College of Cornell University