跳至主要内容
临床试验/NCT06969703
NCT06969703尚未招募不适用

Azole Susceptibility and Resistance Mechanisms Surveys in Pathogenic Fungi by the China Antifungal Resistance Surveillance Trial (CARST)-Fungi (2023-2024)

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
The type and spectrum of azole-resistance in the pathogenic fungi

研究概览

简要总结

The China Antifungal Resistance Surveillance Trial (CARST-fungi) study, which has been starting in July 2019, is a multi-center, prospective, observational, and laboratory-based study of pathogenic fungal isolates causing IFDs. All fungal isolates recovered from clinical samples will be collected. For each episode of fungal isolation, the information including the patient's age, gender, the ward location, the time of sample collection, and specimen type will be collected. All isolates will be sent to the Research Center for Medical Mycology, Beijing, China, for further study including species identification and azole susceptibility testing. Azole-resistant mechanisms will be elucidated by gene sequencing or expression level assay for resistance-related genes.

详细描述

Invasive fungal diseases (IFDs) are life-threatening diseases with considerable morbidity and mortality, primarily occurring in immunocompromised and critically ill hosts. Azoles represent the most widely prescribed antifungal class for IFDs. However, azole-resistance has become a growing problem worldwide. The major resistance mechanisms include mutations or overexpression of the drug target gene ERG11/cyp51, and overexpression of drug efflux pumps. Different resistance mechanisms vary by species and geographic distribution, and the underlying mechanisms in some species have not been well defined. A better understanding of antifungal resistance mechanisms will provide insights to reclaim those antifungal drugs as an option for empiric treatment of IFDs. Thus, comprehensive survey of azole susceptibility and resistance mechanisms of pathogenic fungi plays a significant role in understanding epidemiology and antifungal susceptibility such that to guide empirical therapy and aid antifungal stewardship efforts.

Since antifungal susceptibilities of pathogenic fungi are changing gradually year by year, the investigator put forward the following objectives and hypotheses of our survey:

Objectives

  1. To survey azole-susceptibility status and evolutionary trend of pathogenic fungi isolated from tertiary hospitals in China
  2. To elucidate the mechanisms and characteristics of azole-resistance in different pathogenic fungi

Hypotheses

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • fungal disease

排除标准

  • non-fungal disease

结局指标

主要结局

The type and spectrum of azole-resistance in the pathogenic fungi

时间窗: By the end of Dec. 2025

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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