Clinical trial NCT06200389: Epidemiological Study of Vulvovaginal Candidiases Strain Types and Risk Factors Among Gynecological Outpatients in China
Official title: Epidemiological Study of Vulvovaginal Candidiases Strain Types and Risk Factors Among Gynecological Outpatients From Multiple Sites in China
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vulvovaginal Candidiases
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with Vulvovaginal Candidiasis symptomatology and positive culture

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

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