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

NCT ID: NCT06200389

Last Updated: 2024-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-07-01

Brief Summary

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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

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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.

Conditions

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Vulvovaginal Candidiases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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microbiology testing

Vulvovaginal Candidiases patients diagnosed by microbiology testing can be included

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Qinping Liao

Role: CONTACT

+86-13701124527

Lei Zhang

Role: CONTACT

+86-18601130459

Other Identifiers

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MA-VVC-EI-001

Identifier Type: -

Identifier Source: org_study_id

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