NCT00426933已完成2 期
Phase 2 Multicenter Randomized Semi-Single Blind Study to Compare Efficacy and Safety of High-dose Short Duration Daptomycin With Conventional Therapy in Complicated Skin and Skin Structure Infections Due to Gram-positive Bacteria
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 100 人开始时间: 2007年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Clinical Response Rate at TOC
研究概览
简要总结
multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for 7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g. q12h for up to 14 days.
详细描述
multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for 7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g. q12h for up to 14 days.
The main criteria for evaluation will be:
- Efficacy
- Safety
- Microbiologic eradication
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained
- •Male or female ≥18 years of age
- •If female of childbearing potential, willing to practice reliable birth control measures and documented negative pregnancy test
- •Skin and skin structure infections of a complicated nature that require intravenous antibiotic treatment
- •Gram-positive infecting pathogen
- •Physician determination that vancomycin would be the initial treatment of choice
- •At least three clinical signs and symptoms associated with the cSSSI:
- •Tenderness to palpation;
- •Elevated Temperature;
- •Elevated White blood count;
- •Swelling and/or induration;
- •Erythema (>1 cm beyond edge of wound or abscess);
- •Pus formation;
- •Creatinine clearance of ≥50 mL/min.
排除标准
- •Known or suspected bacteremia, osteomyelitis, or endocarditis
- •Primary study infection of an uncomplicated nature such as furuncles, simple abscesses, cellulitis not requiring i.v., perirectal abscess, hidradenitis suppurativa, third degree burn infections or other minor infections;
- •Conditions where required surgery (in and of itself) constitutes curative treatment of the infection (e.g., amputation);
- •Necrotizing infections or concomitant gangrene;
- •Myositis with or without skin and skin structure infections;
- •Hemodialysis or peritoneal dialysis;
- •BMI ≥40 kg/m2;
- •Previous antibiotics exceeding 24 hours within the 48 hours prior to the first dose of study drug
- •Patients admitted for rhabdomyolysis including drug overdose
- •Neutropenic patients with absolute neutrophil count ≤500 cells/mm3
- •Known HIV-infected patients with CD4 count ≤200 cells/ mm3;
- •Baseline CPK values ≥2 X ULN (upper limit of normal);
- •Has received an investigational drug within 30 days of study entry;
- •Known to be allergic or intolerant to study medications;
- •unlikely to comply with study procedures
- •Is expected to receive HMG CoA Reductase Inhibitors from enrollment through End of Treatment
结局指标
主要结局
Clinical Response Rate at TOC
次要结局
- difference between clinical response rates at EOT
- microbiological eradication rates
研究者
研究点 (2)
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