NCT00790608终止2 期
A Phase II Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus in MRSA Positive Ulcers
Nitric BioTherapeutics, Inc2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2009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
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in bioburden (specifically MRSA)as assessed via quantitative cultures.
研究概览
简要总结
The purpose of the study is to determine if topically applied nitric oxide gas is effective in reducing the quantity of bacteria (including MRSA)in a wound.
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
- 18 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 ≥ 18 years of age and not of child bearing potential
- •Must have an ulcer in which the presence of MRSA has been identified, but which is not clinically infected
- •Must have an ulcer size not to extend beyond the inner borders of the dressing
排除标准
- •Is a female of child bearing years or who could become pregnant
- •Is < 18 years of age
- •Has an clinically infected skin ulcer
- •Has a ulcer that is being treated with a topical antimicrobial agent 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 which is identified as malignant in origin (e.g. Marjolin's ulcer)
- •Has an ulcer size beyond the inner borders of the dressing
- •Is septic or has other signs of an invasive infection
- •Has used any investigational drug 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
结局指标
主要结局
Change in bioburden (specifically MRSA)as assessed via quantitative cultures.
时间窗: 10 Days
次要结局
- Improvement in the condition of the ulcer as judged by comparative photography and independent clinical assessment(10 Days)
- Incidence of adverse events(10 Days)
研究者
研究点 (2)
Loading locations...
相似试验
终止
1 期
Reduction of Bacteria in MRSA Positive UlcersLeg UlcerPressure UlcerNCT00771368Nitric BioTherapeutics, Inc20
进行中（未招募）
不适用
A Phase II Trial on the Reduction of Meticillin Resistant Staphylococcus Aureus in MRSA Positive Ulcerslcers in which the presence of meticillin resistant Staphylococcus aureus (MRSA) has been identified.MedDRA version: 9.1Level: LLTClassification code 10045285Term: UlcerEUCTR2008-001287-36-GBitric BioTherapeutics, Inc
已完成
4 期
Perioperative Nitric Oxide Prevents Acute Kidney Injury in Acute Type A Aortic Dissection PatientsAcute Kidney InjuryNCT06622291Beijing Anzhen Hospital106
终止
2 期
Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg UlcersVenous UlcersNCT00613808Nitric BioTherapeutics, Inc6
已完成
2 期
A Dose Response Trial to Evaluate Clinical and Mycological Effect of Nitric Oxide in Subjects With Tinea PedisTinea PedisNCT00893880Nitric BioTherapeutics, Inc92