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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06200389
Other study ID # MA-VVC-EI-001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date July 1, 2025

Study information

Verified date October 2023
Source Beijing Tsinghua Chang Gung Hospital
Contact Qinping Liao
Phone +86-13701124527
Email 13701124527@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 2000
Est. completion date July 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Diagnostic Test:
microbiology testing
Vulvovaginal Candidiases patients diagnosed by microbiology testing can be included

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tsinghua Chang Gung Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Composition and distribution of strains from gynecological Vulvovaginal Candidiasis outpatients in China From January 2024 to January 2025
Secondary Evaluate the sensitivity and resistance of commonly used antifungal treatments From January 2024 to January 2025
Secondary Evaluate risk factors of gynecological Vulvovaginal Candidiasis outpatients in China From January 2024 to January 2025
Secondary 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
Secondary Consistency analysis of clinical and microbiological diagnosis from gynecological Vulvovaginal Candidiasis outpatients in China From January 2024 to January 2025
Secondary Estimate the proportion of various types of Vulvovaginal Candidiasis in gynecological outpatients in China From January 2024 to January 2025
Secondary Evaluate neuropsychic behaviour of Vulvovaginal Candidiasis patients in gynecological outpatients nationwide From January 2024 to January 2025
See also
  Status Clinical Trial Phase
Completed NCT03064789 - Epidemiological Study in Subjects With Vulvovaginal Candidiases
Withdrawn NCT03167957 - Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis Phase 2