Nuvocid® (Oritavancin) at Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections (SIMPLIFI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Clinical success at follow-up
研究概览
简要总结
Two Phase III trials to demonstrate the efficacy and safety of oritavancin in the treatment of complicated skin and skin structure infections (cSSSI) have been completed.
The pharmacokinetic profile of oritavancin in humans suggests that oritavancin has the potential to be used safely and effectively when given either as a single dose or as an infrequent dose for cSSSI. Data from animals support this theory.
SIMPLIFI has been designed to evaluate the efficacy and safety of either a single dose of oritavancin or an infrequent dose of oritavancin (First dose on Day one with an option for a second dose on Day five) compared to the previously studied dosing regimen of 200mg oritavancin given once daily for 3 to 7 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- •with a condition which would prevent performing protocol safety and efficacy assessments.
- •who have received antibiotics for more than 24 hours within the last 3 days.
- •with an infection involving deep tissues or unlikely to be caused by gram positive bacteria
- •who are nursing and will not stop nursing for at least 6 months
- •with a prior allergic reaction to glycopeptides (e.g. vancomycin)
- •with any of the following:
- •toxic shock syndrome or toxic-like syndrome
- •presumed or proven infection caused by Clostridium species
- •bone infections
- •ischemic or gangrenous ulcers or wounds
- •infections caused only by gram-negative bacteria
- •infection of an artificial joint that cannot be removed
- •infection of the scrotum, perineum or perianal region
- •infection of a severe burn wound
- •severe ear infection involving bone and/or cartilage
- •infection following injury in water possibly containing Vibrio species or following a history of eating raw oysters within 1 week prior to disease onset
研究组 & 干预措施
3
干预措施: oritavancin (Drug)
1
干预措施: oritavancin (Drug)
2
干预措施: oritavancin (Drug)
结局指标
主要结局
Clinical success at follow-up
时间窗: six months
次要结局
- To evaluate safety of dosing regimens.(six months)