跳至主要内容
临床试验/CTRI/2022/07/044246
CTRI/2022/07/044246招募中不适用

Comparison of the clinico-microbiological features and outcomes in patients with bacterial keratitis caused by biofilm producing and non –biofilm producing bacteria

Hyderabad Eye Research Foundation1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2022年7月29日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
119
试验地点
1
主要终点
•Proportion of patients with bacterial keratitis infected with biofilm positive and biofilm negative bacteria.

研究概览

简要总结

Bacterial keratitis is an infection of cornea causedby invasion and multiplication of bacteriaassociated with inflammation ofstroma .

Pain , redness, photophobia and blurred vision aretypical symptoms. Bacterial keratitis cancomplicate to corneal scarring andeven perforation, which can lead to total visual loss  .

Corneal opacity is the fifth leading cause ofblindness globally, affecting approx. 6 million ofworldpopulation. Inadditionit is responsible for 1.5-2.0 million new cases of monocular

blindness highlighting an ongoing uncurbed burden onhuman health.

Contact lens wear is the most common risk factor forbacterial keratitis in urbanized world,while in developing country like India,trauma with contaminated water, soil and vegetative

matter which deliver heavy microbial loads, foreignbodies and diverse microbiota to ocular surface  .The most common causative organism forbacterial keratitis is Staphylococcusspp.,

Streptococcus spp. and gram negative bacilli such asPseudomonas spp., and many of themare associated with biofilm production  .

Biofilm is a slimy layer of a extra cellular matrixmade of polymeric substances, formed by sessile cells and can grow onto bothbiotic and abiotic surfaces.Biofilms form an architectural colony providingresistance not only against antibiotics but also against human

immune system. Biofilm provides protection tobacteria from altered pH, osmolarity, nutrient scarcity , mechanical forces andconfers antibiotic resistance through numerous mechanisms, thus making thesebacteria very dangerous and difficult to treat.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • The study includes patients of any age or sex diagnosed withculture positive bacterial keratitis.

排除标准

  • 1 Fungal keratitis 2 Culture negative keratitis 3 Photo keratitis 4 Neurotrophic keratitis 5 Exposure keratitis 6 Inflammatory keratitis like Mooren’s ulcer.

结局指标

主要结局

•Proportion of patients with bacterial keratitis infected with biofilm positive and biofilm negative bacteria.

时间窗: 1st visit and last visit

•Profile of antibiotic resistance in the bacterial isolates positive for biofilm and negative for biofilm.

时间窗: 1st visit and last visit

•Comparison of the following clinical parameters in patients of bacterial keratitis with biofilm positive and biofilm negative bacteria.

时间窗: 1st visit and last visit

oRate of corneal ulcer healed

时间窗: 1st visit and last visit

oVisual acuity

时间窗: 1st visit and last visit

oRate of patients with worsening despite treatment

时间窗: 1st visit and last visit

oNeed for surgical intervention

时间窗: 1st visit and last visit

次要结局

  • Type of bacteria causing bacterial keratitis will be assessed for, and it would be done based on microbiology report of corneal scrapping(1st visit)

研究者

申办方类型
Research institution

研究点 (1)

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