NCT00295178已完成4 期
A Multicenter, Randomized Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in the Treatment of Cellulitis or Erysipelas
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2006年2月20日最近更新:
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试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- investigating the differences in speed and degree of symptom resolution between CUBICIN and vancomycin
研究概览
简要总结
This study is designed to investigate the difference in speed and degree of symptom resolution between daptomycin and vancomycin in subjects treated for cellulitis or erysipelas by evaluation of the following parameters:
- Time to erythema margin cessation to progress
- Time to defervescence
- Time to hospital discharge following relief of the presenting cellulitis or erysipelas
- Degree of improvement of the following signs and symptom of cellulitis or erysipelas including
- Degree of improvement of cellulitis-related pain and swelling as reported by subjects
Additionally, the difference in frequency of Adverse Events between daptomycin and vancomycin will be described.
详细描述
same as above
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
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
- •Read and sign the informed consent form after the nature of the study has been fully explained;
- •Male or female > or = 18 years of age;
- •If female of childbearing potential, a negative pregnancy test is required;
- •Primary diagnosis of cellulitis/ erysipelas
- •with onset of signs or symptoms within 3 days of 1st dose of study medication
- •requiring hospitalization, and severe enough to warrant IV antibiotics
- •temperature >37.5°C (99.5° F) oral or >38° C (100.2° F) rectal, documented within 48 hours prior to enrollment, and
- •anticipated treatment to be limited to medical (NOT surgical) interventions
- •at an anatomical location that allows of a clear assessment of the erythema margin
排除标准
- •Pregnant or lactating female;
- •Conditions where required surgery (in and of itself) constitutes curative treatment of the infection or removal of infected site (e.g., amputation);
- •Conditions requiring emergent surgical intervention at the site of infection (e.g., progressive necrotizing infections);
- •Previous systemic antimicrobial therapy exceeding 24 hours duration, administered anytime during the 72 hours prior to the first dose of study drug unless on previous antibiotics for at least 72 hours and without any clinical improvement;
- •Cellulitis associated with a wound infection or ulcer requiring incision and drainage or debridement
- •Perirectal abscess or hidradenitis suppurativa or third degree burn infections
- •Buccal cellulitis, facial cellulitis, perianal cellulitis, or periorbital cellulitis;
- •Known or suspected osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection;
- •Known to be allergic or intolerant to study medications;
- •Subjects with a Creatinine Clearance (CLCR) <30 mL/min;
- •Requirement for non-study systemic antibiotics;
- •Requirement for systemic steroids from enrollment through stabilization of cellulitis;
- •Rhabdomyolysis;
- •Neutropenic subjects with absolute neutrophil count ≤ 500 cells/mm3
结局指标
主要结局
investigating the differences in speed and degree of symptom resolution between CUBICIN and vancomycin
次要结局
- frequency of Serious Adverse Events between daptomycin and vancomycin will be described
研究者
研究点 (2)
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