CTRI/2017/07/009091已完成1 期
A Prospective, Randomized, Parallel group Study to Evaluate the Safety and Efficacy of FDC of Mupirocin calcium, Neomycin Sulfate & HT61 HCL in Patients with infected skin lesions by Staphylococcus aureus including Methicillin-resistant Staphylococcus aureus (MRSA) and or S. Pyogenes. - CRSC16001
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Healthy male or non-pregnant females aged greater or equal to 18 years with an infected skin lesion including laceration, sutured wound, or abrasion.
- •2.The laceration or sutured wound should be between 1-10 cm in length and not requiring systemic antibiotic treatment as per PI discretion.
- •3.Gram stains for presence of bacteria and Wrightâ??s stain for confirmation of white blood cells in the pus/exudate from the infected skin lesion.
- •4.Positive baseline culture for S. aureus and/or S. pyogenes from a sample taken from the infected skin lesion.
- •5.Skin Infection Rating Scale (SIRS) total score for the infected skin lesion of at least 8 at baseline.
- •6.Patients must be willing to provide written informed consent.
- •7.Patients must be willing and able to understand and comply with the requirements of the study, apply the medication as instructed and be able to complete the study.
- •8.Patients must be in good health and free from any clinically significant disease, other than infected skin lesions, that might interfere with the study evaluations.
排除标准
- 未提供
研究者
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