Cubicin(R) for Complicated Post-surgical Wound Infections
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 69
- 主要终点
- Investigator's assessment of clinical response based on improvement of signs and symptoms
研究概览
简要总结
The purpose of the study is to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections
详细描述
A multi-center, single-arm, open-label, non-comparative study to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections. Adjunctive treatment with aztreonam and/or metronidazole could be given for Gram-negative and/or anaerobic organisms. Patients are to be treated for a period of 7-14 days as specified in the package insert. An evaluation is to be performed on the day CUBICIN treatment is completed (assessment for outcome of cure, improved, failure or unable to evaluate). A follow-up is required for patients with an Investigator response of 'Improved' at the end of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Read and signed informed consent form
- •female of childbearing potential, negative pregnancy test result
- •Confirmed diagnosis of post-surgical wound infections known or suspected (based on Gram stain) to be due to Gram-positive organisms obtained within 3 calendar days prior to first dose of study medication
- •Onset of surgical wound infection within 30 days after surgery
- •At least three clinical signs and symptoms of skin infection
排除标准
- •previous systemic antimicrobial therapy exceeding 24 hours duration administered anytime during 72 hours prior to the first dose of study drug
- •Uncomplicated surgical infections (eg, stitch abscesses)
- •osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection
- •Any type of space infection
- •Conditions requiring surgical removal of wound infection
- •necrotizing fasciitis, synergistic gangrene, Clostridial myonecrosis (gas gangrene), or Fournier's gangrene;
- •Foreign material involved in the post-surgical wound infection
- •Known to be allergic or intolerant to study medication
- •Creatinine Clearance (CLCR) <30 mL/min
- •history of neurological disease (eg, Guillain-Barré, multiple sclerosis)
结局指标
主要结局
Investigator's assessment of clinical response based on improvement of signs and symptoms
时间窗: End of Therapy
次要结局
- Incidence of adverse events(first dose to end of therapy)
- eradication of pathogens isolated at admission(End of Therapy)
- overall therapeutic outcome based on agreement between clinical efficacy and microbiological response(End of Therapy)