跳至主要内容
临床试验/CTRI/2020/12/029629
CTRI/2020/12/029629Other不适用

"Use of antibiotics in the Medical Management of Pythium Keratitis: Pilot Study"

L V Prasad Eye Instituta1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2020年7月12日最近更新:

试验速览

阶段
不适用
状态
Other
发起方
入组人数
5
试验地点
1
主要终点
Healing of keratities

研究概览

简要总结

Cornealinfection caused by Pythium Insidiosum is a highly morbid and sight threateningdisease.1 It can be identified by the zoospore formation method onculture.2 Being an oomycete it has a cell wall made of cellulose andchitin and hence there is poor response to anti-fungal drugs targeting the ergosterolbiosynthesis pathway.3 It is known to respond poorly to commonlyused therapy such as anti-fungals, antibiotics and also has a high recurrencefollowing therapeutic penetrating keratoplasty(TPK).1,4  We reported relative success with combinationof antibacterial antibiotics as a primary treatment which was formulated basedon in-vitro susceptibility.5 Subsequently we also reported thatfewer patients underwent TPK with this regime, the outcomes were better interms of elimination of infection and there was a reduced recurrence rate.6 In-vitro susceptibility tests provide clinically relevant informationthat would aid in appropriate selection of drugs.7 We have tried combination of Linezolidand azithromycin for the treatment of Pythium keratitis. Based on the Pythiuminviro and animal trial Tigecycline seems to be nice alternative for Pythiumkeratitis. We are planning pilot trial to see its efficacy in combination withLinezolid and see its efficacy as combination therapy.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Age equal to or more than 18 years.
  • Male or female 3) Stromal infiltrate size between 2-8 mm.
  • Corneal scraping positive for Aseptate broad ribbon like filaments characteristic of Pyhthium in direct smear examination by any one or more of the methods used.

排除标准

  • The corneal scrapings are negative for Pythium 2)The patient has a history of allergy to any of drugs used.
  • The cornea or sclera has been perforated or perforation is impending.

结局指标

主要结局

Healing of keratities

时间窗: 1 week, 2 week, 3 week, 1 month, 3 month, 6 months

次要结局

  • Visual acuity, number of PK required(1 week, 2 week, 3 week, 1 month, 3 month, 6 month)

研究者

发起方
L V Prasad Eye Instituta
申办方类型
Other [Non Profitable Organization]

研究点 (1)

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