NCT00303589已完成2 期
A Phase II Prospective, Open Label, Randomized, Active-controlled, Parallel Group, Multi-center 'Proof of Concept' Trial in Adult Patients With Complicated Skin or Skin Structure Infections Requiring Hospitalization.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 313
- 主要终点
- Clinical cure rate.
研究概览
简要总结
This 3 arm study will compare the efficacy and safety of beta-lactam with that of 'standard care' in patients with complicated skin and skin structure infections requiring hospitalization. Patients will be randomized to receive 1)beta-lactam 750mg iv q8h 2)beta-lactam 1500mg iv q8h or 3)'standard care' [PRP (nafcillin or flucloxacillin) or vancomycin, plus aztreonam or ciprofloxacin]. The anticipated time on study treatment is <3 months and the target sample size is 100-500 individuals.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, >=18 years of age;
- •skin or skin structure infection requiring hospitalization;
- •clinical diagnosis of a skin or skin structure infection caused by bacteria known or suspected to be susceptible to the randomized study treatment;
- •material from site of infection is clinically purulent or seropurulent.
排除标准
- •presenting with sustained shock (SBP<90mm Hg for > 2 hours, despite adequate fluid resuscitation);
- •known or suspected concomitant bacterial infection requiring antibiotic treatment;
- •skin infection or chronic non-healing ulcer of > 2 weeks duration;
- •patients in whom surgery is the primary treatment.
研究组 & 干预措施
1
Experimental
干预措施: beta-lactam (Drug)
2
Experimental
干预措施: beta-lactam (Drug)
3
Active Comparator
干预措施: Standard care (Drug)
结局指标
主要结局
Clinical cure rate.
时间窗: Event driven
次要结局
- Bacteriological outcome(Event driven)
- Time to clinical cure(Event driven)
- Time to resolution of signs and symptoms of skin or soft tissue infection(Event driven)
- Adverse events; laboratory abnormalities(Throughout study)
研究者
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Unknown
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