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.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Comparison of adverse events for test treatment between three study groups.
研究概览
简要总结
This Prospective, Randomized, Parallel group, clinical study is designed to evaluate safety and efficacy of test cream in 30 eligible patients with infected skin lesions by Staphylococcus aureus including MRSA and/or S. Pyogenes. The cream will be applied for 3 times daily for 7 days and study will be conducted in three centers in India.
The objective of this study is to compare safety profile of test cream between three study groups. Clinical and bacteriological cure rate of test cream will also be compared between the three study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
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 Wright’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
结局指标
主要结局
Comparison of adverse events for test treatment between three study groups.
时间窗: On Day 7 & and Day 14.
次要结局
- Reduction in Colony Forming Units from baseline(On Day 03, 05 and 07.)
研究者
研究点 (5)
Loading locations...
相似试验
已完成
不适用
Mixed Reality-Based Rehabilitation Software for Chronic Secondary Musculoskeletal PainNCT06936059Xinhua Hospital, Shanghai Jiao Tong University School of Medicine80
Unknown
4 期
Effect of Sodium Rinsing Fluid on Blood Pressure and Interdialytic Weight Change in Hemodialysis PatientsEnd-Stage Kidney DiseaseHemodialysisNCT02590081Penang Hospital, Malaysia434
已完成
2 期
MARIGOLD Study: A Study of RO4917523 Versus Placebo as Adjunctive Therapy in Patients With Major Depressive Disorder and an Inadequate Response to Ongoing Antidepressant TherapyMajor Depressive DisorderNCT01437657Hoffmann-La Roche319
尚未招募
4 期
a clinical trial to compare efficacy of the analgesic activity of inj. Bupivacaine vs inj. Ropivacaine given at transverse abdominis block and also compare the safety parameters also.CTRI/2017/08/009249Department of Anaesthesiology60
已完成
不适用
Directly Observed Therapy Short Course-Plus Versus DOTS for Retreatment of Relapsed Pulmonary Tuberculosis in GuangzhouPulmonary TuberculosisNCT01618422Chinese University of Hong Kong225