A Clinico-Mycological, Therapeutic and Antifungal drug sensitivity study of Extensive dermatophytosis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 1.Cinical profile of dermatophytic infections prevalent in this region will be noted.
研究概览
简要总结
This study is a randomised, double blind, parallel group, multi arm trial comparing the therapeutic efficacy of anti fungal drugs in extensive dermatophytic infections. A detailed history and clinical examination will be done. In all suspected cases of dermatophytic infections, specimen for direct microscopy will be collected by scraping the active edge of the affected skin. Material will be subjected to direct microscopic examintaion using 10%KOH. A part of the collected specimen will be sent for fungal culture in sterile specimen bottle. For primary isolation, Sabourads dextrose agar slopes will be used and Dermatophyte test medium will be used as selective medium. Species identification will be done by colony morphology and microscopy on Lactophenol cottobn blue mount. Antifungal drug sensitivity testing will be done by Broth microdilution test using Clinical and laboratory standard institute M38-A standards. All KOH positive cases will be divided into 5 groups of 30 each by randomistaion using computer based softwares and are given systemic antifungals to know the therapeutic efficacy after 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Clinically diagnosed cases of extensivedermatophytoses infection affecting more than one region of the body.
- •Both sexes between the age groups
- •70 yrs 3.Patients who have not used topical and systemic antifungal drugs for the past 6 weeks.
排除标准
- •1.Infants, below 18 yrs, above 70 yrs 2.Immunocompromised patients including HIV are excluded.
- •3.Pregnancy and lactating patients are excludued.
- •4.Patients receiving multiple drugs for medical conditions including glucocorticosteroids.
结局指标
主要结局
1.Cinical profile of dermatophytic infections prevalent in this region will be noted.
时间窗: 8 weeks
2.Mycological profile of dermatophytic infections including species identification prevalent in this region will be noted.
时间窗: 8 weeks
3.Sensitivity pattern of isolates against terbinafine, itraconazole,griseofulvin will be studied and recorded.
时间窗: 8 weeks
4.Therapeutic efficacy of single and in combinations of systemic antifungal drugs in extensive dermatophytic infections will be reported.
时间窗: 8 weeks
次要结局
- 1. To note the recurrences in the follow up period of 6 months.(6 months)