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临床试验/NCT06508398
NCT06508398已完成不适用

Species Spectrum and Biological Properties of Bacterial and Fungal Causative Agents of Health-care-associated Infections and in Vitro Study of Antimicrobial Activity Against Them Using 4-thiazolidinone Derivatives.

Danylo Halytsky Lviv National Medical University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
250
试验地点
1
主要终点
Incidence of Healthcare-Associated Infections (HAIs)

研究概览

简要总结

The goal of this observational study is to evaluate the species spectrum and biological properties of bacterial and fungal pathogens causing healthcare-associated infections (HAIs) and to investigate the antimicrobial activity of new 4-thiazolidinone derivatives. The main questions it aims to answer are:

What are the common pathogens responsible for HAIs in ICU patients? What is the antimicrobial and antifungal efficacy of 4-thiazolidinone derivatives against these pathogens?

Participants will have their clinical samples collected and analyzed for pathogen identification and susceptibility testing. The study will involve:

Collecting clinical data and samples from ICU patients Conducting microbiological and biochemical tests Screening new antimicrobial compounds for efficacy The study does not involve a comparison group as it focuses on observational data and laboratory analysis.

详细描述

The study aims to characterize the structure and distribution of Healthcare-Associated Infections (HAIs) in Ukraine in recent years, features of the species spectrum of pathogens, and the spreading of antibiotic resistance, clinical and microbiological characteristics of HAIs, including those caused by rare pathogens of HAIs, as well as a search, synthesis, screening of new chemical compounds with antimicrobial and antifungal activity in order to introduce new prototypes of antimicrobial drugs.

According to the study design, and analysis of the data of the CDC of Ukraine on the registration of HAIs cases in Ukraine during 2009-2020 was conducted. As a result, for the first time in Ukraine, the registration of HAIs for the last 12 years was analyzed; according to the results, an average of 4,759 ± 710 cases of HAIs have been registered annually. The analyzed materials give grounds to claim a significant underestimation of the incidence of HAIs in the country.

According to the results of a comprehensive, dynamic, clinical, and laboratory-instrumental examination of 250 patients of 4 local hospitals' ICU departments, and based on microbiological and epidemiological criteria, the corresponding diagnosis was confirmed in 205 patients. Among persons with HAIs, 46.8% were men, and 53.2% were women. Among all cases of HAIs, 24.9% were children (including 8.8% newborns), 64.9% - people aged 18-60 years, older adults (> 60 years) were 10.2%. The most common nosologies were respiratory tract infections (36.6%) and urinary tract infections (34.1%). Most HAIs (58.6%) occurred from the 5th to the 14th day of hospital stay.

Three hundred eighty-nine biomaterials were taken, from which 309 strains of microorganisms were isolated, among which Gram-negative bacteria prevailed (51.5%), the species spectrum of which included representatives of 27 different species. Representatives of the genus Pseudomonas were the most isolated - 50 isolates, 16.2% of the total number of pathogens. Gram-positive microbiota is represented by 15 different species of pathogens, the most - members of the genus Staphylococcus - 52 isolates, which is 16.8% of the total number of pathogens. Among the fungi, 12 different species of pathogens were isolated, most of them Candida non-albicans - 20 isolates, which is 6.5% of the total number of pathogens.

For the first time in Ukraine, clinical cases caused by rare pathogens Raoultella (Klebsiella) terrigena and Vibrio metchikovii have been identified and described. Our reported cases were compared with the clinical cases described in the literature. It was shown that the isolate of R. terrigena has film-forming properties, more pronounced than the standard strain Raoutella terrigena ATCC 33257, and the rate of film formation exceeds the rate of film formation by staphylococci.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Currently hospitalized in an ICU department. Confirmed diagnosis of a nosocomial infection (healthcare-associated infection (HAI)).

排除标准

  • Community-associated pneumonia. Infectious processes that are not related to the provision of medical care.

结局指标

主要结局

Incidence of Healthcare-Associated Infections (HAIs)

时间窗: 12 months

The primary outcome measure is to determine the incidence rate of healthcare-associated infections in ICU patients. This will be achieved by collecting and analyzing clinical samples for the presence of bacterial and fungal pathogens. The effectiveness of new 4-thiazolidinone derivatives against these pathogens will also be assessed through antimicrobial susceptibility testing.

次要结局

  • Pathogen Distribution in Healthcare-Associated Infections(12 months)

研究者

发起方
Danylo Halytsky Lviv National Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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