A Phase II Trial on the Reduction of Meticillin Resistant Staphylococcus Aureus in MRSA Positive Ulcers

itric BioTherapeutics, Inc0 个研究点开始时间: 2008年3月18日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Must have given written informed consent
•- Must be 18 years of age or over and, if female, not of child bearing potential
•- Must have an ulcer in which the presence of MRSA has been positively identified but which is not clinically infected.
•- Must have an ulcer size not to extend beyond the inner borders of the dressing.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•-Is pregnant or a female who could become pregnant
•- Is < 18 years of age
•- Has a clinically infected ulcer
•- Has an ulcer that is currently treated or has been treated with a topical antimicrobial agent during 3 days prior to enrolment.
•- Is using systemic antibiotics or 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 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
•- Is immune deficient
•- Is using any of the prohibited concomitant medications or treatments

发起方

itric BioTherapeutics, Inc