NCT00771368终止1 期
A Clinical Trial on the Reduction of Bacteria (Including MRSA) in MRSA Positive Ulcers and Lesions
Nitric BioTherapeutics, Inc1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction in bacteria
研究概览
简要总结
The purpose of this study is to determine if gaseous nitric oxide is effective in the treatement of bacteria in MRSA positive ulcers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have given written informed consent
- •Must be 19 years of age or over
- •Must have an ulcer or lesion in which the presence of MRSA has been positively identified but which is not clinically infected.
- •Must have an Ulcer / Lesion size not to extend beyond the inner borders of the wound cover
排除标准
- •Is a female who is pregnant, nursing, or of child bearing potential who is not using an adequate form of contraception (or abstinence)
- •Is < 19 years of age
- •Has a clinically infected ulcer
- •Has an Ulcer / Lesion that is currently treated or has been treated with a topical antimicrobial agent during 3 days prior to enrolment.
- •Has been using systemic antibiotics during 7 days prior to enrolment into this study.
- •Has an Ulcer / Lesion which is identified as malignant in origin (e.g., Marjolin's ulcer)
- •Has an Ulcer / Lesion size beyond the inner borders of the wound cover
- •Is septic or has other signs of an invasive infection
- •Has used any other investigational product within 30 days preceding study participation.
- •Suffers from a condition, which, in the opinion of the Investigator,would compromise his or her safety.
- •Suffers from a condition which, in the opinion of the Investigator, would compromise the quality of the data.
- •Has a known allergy to any of the products that are part of this protocol
- •Suffers from a condition which, in the opinion of the Investigator, would seriously interfere negatively with the normal parameters of immune response to an infection.
- •Is using any of the prohibited concomitant medications or treatments
研究组 & 干预措施
Nitric Oxide
Experimental
gaseous nitric oxide delivered topically for 30 minutes
干预措施: Nitric Oxide (Drug)
结局指标
主要结局
Reduction in bacteria
时间窗: Post Treatment Day 3
次要结局
- Incidence of adverse events(3 days)
研究者
研究点 (1)
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