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临床试验/NCT06200389
NCT06200389尚未招募不适用

Epidemiological Study of Vulvovaginal Candidiases Strain Types and Risk Factors Among Gynecological Outpatients From Multiple Sites in China

Beijing Tsinghua Chang Gung Hospital0 个研究点目标入组 2,000 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
2,000
主要终点
Composition and distribution of strains from gynecological Vulvovaginal Candidiasis outpatients in China

研究概览

简要总结

We has proposed to conduct a national epidemiological study on the pathogenic strains and high risk factors of Vulvovaginal Candidiasis in China , and conduct drug resistance analysis.

详细描述

Vulvovaginal Candidiasis is a mucosal infectious disease, which rarely occurs fatal infection, but has high recurrence rate. Vulvovaginal Candidiasis often leads to decreased life quality and serious economic burden. However, we known little about the pathogenesis of Vulvovaginal Candidiasis. So better diagnosis and treatment methods are needed to decrease the impact on women's health.

In 2017, the national Vulvovaginal Candidiasis epidemiological survey led by Professor Liao showed that 543 strains of fungi were isolated from different patients from 12 hospitals in 10 cities in China, of which Recurrence Vulvovaginal Candidiasis strains accounted for 15.7%. The most common pathogenic strain was Candida albicans (460 species, 84.71%), and the most common non-albicans was Candida glabra (47 species, 8.66%). In addition, 92 isolates (20.4%) belonged to the new branch endemic to North China. Vaginal symptoms of Vulvovaginal Candidiasis caused by non-albicans are usually milder compared to Vulvovaginal Candidiasis caused by Candida albicans. However, inherent resistance to azoles, as well as acquired resistance mechanisms, can complicate the treatment of non-albicans and often requires a long-term antifungal treatment or other treatments to clear non-albicans.

Given that the resistance rate of different types of candida to antifungal drugs changes over time, common antifungal drugs have selective induction of resistance to fungi, and fungi have cross-induction of resistance to antifungal drugs, it is very important to evaluate the distribution and resistance of Candida species in a long-term . Accurate and effective acquisition of candida epidemiological data to understand the recent status and drug resistance of Candida infection can effectively guide clinical treatment to improve the therapy, and play a very important role in clinical diagnosis and treatment. Therefore, Professor Liao has proposed to conduct a national epidemiological study on the pathogenic strains and high risk factors of Vulvovaginal Candidiasis in China once again, and conduct drug resistance analysis, in order to guide clinicians to better Vulvovaginal Candidiasis treatment.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Outpatients of gynecology
  • Age≧18 years
  • Signed informed consent form voluntarily
  • With diagnosis and symptomatology of Vulvovaginal Candidiasis (all types of Vulvovaginal Candidiasis can be included)
  • History of sexual life

排除标准

  • Antifungal medication was used within 7 days (oral or topical)
  • With contraindications of vaginal sampling
  • Other conditions deemed unsuitable for inclusion by clinicians

结局指标

主要结局

Composition and distribution of strains from gynecological Vulvovaginal Candidiasis outpatients in China

时间窗: From January 2024 to January 2025

次要结局

  • Evaluate risk factors of gynecological Vulvovaginal Candidiasis outpatients in China(From January 2024 to January 2025)
  • Estimate the proportion of different ages of gynecological Vulvovaginal Candidiasis outpatients in China (Childbearing age and non-childbearing age)(From January 2024 to January 2025)
  • Evaluate neuropsychic behaviour of Vulvovaginal Candidiasis patients in gynecological outpatients nationwide(From January 2024 to January 2025)
  • Estimate the proportion of various types of Vulvovaginal Candidiasis in gynecological outpatients in China(From January 2024 to January 2025)
  • Evaluate the sensitivity and resistance of commonly used antifungal treatments(From January 2024 to January 2025)
  • Consistency analysis of clinical and microbiological diagnosis from gynecological Vulvovaginal Candidiasis outpatients in China(From January 2024 to January 2025)

研究者

申办方类型
Other
责任方
Sponsor

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