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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06200389
Enrollment
2000
Registered
2024-01-11
Start date
2024-01-01
Completion date
2025-07-01
Last updated
2024-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvovaginal Candidiases

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.

Interventions

DIAGNOSTIC_TESTmicrobiology testing

Vulvovaginal Candidiases patients diagnosed by microbiology testing can be included

Sponsors

Beijing Tsinghua Chang Gung Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Composition and distribution of strains from gynecological Vulvovaginal Candidiasis outpatients in ChinaFrom January 2024 to January 2025

Secondary

MeasureTime frame
Evaluate risk factors of gynecological Vulvovaginal Candidiasis outpatients in ChinaFrom 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 the sensitivity and resistance of commonly used antifungal treatmentsFrom January 2024 to January 2025
Estimate the proportion of various types of Vulvovaginal Candidiasis in gynecological outpatients in ChinaFrom January 2024 to January 2025
Evaluate neuropsychic behaviour of Vulvovaginal Candidiasis patients in gynecological outpatients nationwideFrom January 2024 to January 2025
Consistency analysis of clinical and microbiological diagnosis from gynecological Vulvovaginal Candidiasis outpatients in ChinaFrom January 2024 to January 2025

Contacts

Primary ContactQinping Liao
13701124527@163.com+86-13701124527
Backup ContactLei Zhang
18601130459@163.com+86-18601130459

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026