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临床试验/CTRI/2022/01/039186
CTRI/2022/01/039186尚未招募不适用

To evaluate antibiogram and occurrence of bacterial biofilm in leprosy plantar ulcers

IADVL research grant1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2022年1月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
65
试验地点
1
主要终点
organism for biofilm production

研究概览

简要总结

Sixty-fiveleprosypatients with plantar ulcers attending Dermatology OPD over 24 months period will beenrolled after obtaining informed consent. Swabs will be collected from Plantarulcers. Isolation and identification of bacteria will be performed, based onculture and standard bacterial identification methods. Antimicrobialsusceptibility testing will be conducted using the disk diffusion test.Detection of biofilm production will be carried out using the Micro Titre Platemethod (MTP). The pattern of antibiotic resistance exhibited bybiofilm-producers will be compared with non-biofilm-producers.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • a) Leprosy patients with plantar ulcers who are not on topical or systemic antibiotics since atleast 2 weeks b) Age above 18 years.

排除标准

  • patients with a history of use of topical or systemic antibiotics within 2 weeks.
  • Patients with ulcer who are admitted in hospital since atleast 5 days which can alter bacterial colonization.

结局指标

主要结局

organism for biofilm production

时间窗: 3 days

measurement of biofilm production by the Microtitre plate method (MTP) will be performed for in clinical isolates of bacteria. An optical

时间窗: 3 days

between 0.120–0.240 a moderate biofilm producer and an OD of less than 0.120,

时间窗: 3 days

Quantitative

时间窗: 3 days

density (OD) greater than 0.240 indicated a strong biofilm producer, an OD

时间窗: 3 days

a non-biofilm producer. S. aureus ATCC 25923 will be used as the control

时间窗: 3 days

次要结局

  • The antimicrobial susceptibility testing (AST) determined by the Kirby-Bauer(disc diffusion method after it is incubated for 18–24 h at 37 °C aerobically, the)

研究者

发起方
IADVL research grant
申办方类型
Research institution

研究点 (1)

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