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Vulvovaginal CandidiasesNCT06200389

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

An observational study of Vulvovaginal Candidiases, run by Beijing Tsinghua Chang Gung Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Vulvovaginal Candidiases
What is being tested?
microbiology testing
How many people
2,000 participants
Where
No sites listed yet
Study dates
1 Jan 2024to 1 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Women with Vulvovaginal Candidiasis symptomatology and positive culture

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

About this study

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

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.

Read the 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.

Being tested
microbiology testing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • microbiology testingDiagnostic test

    Vulvovaginal Candidiases patients diagnosed by microbiology testing can be included

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: From January 2024 to January 2025

Secondary outcomes (6)
  1. Evaluate the sensitivity and resistance of commonly used antifungal treatments

    Measured: From January 2024 to January 2025

  2. Evaluate risk factors of gynecological Vulvovaginal Candidiasis outpatients in China

    Measured: From January 2024 to January 2025

  3. Estimate the proportion of different ages of gynecological Vulvovaginal Candidiasis outpatients in China (Childbearing age and non-childbearing age)

    Measured: From January 2024 to January 2025

  4. Consistency analysis of clinical and microbiological diagnosis from gynecological Vulvovaginal Candidiasis outpatients in China

    Measured: From January 2024 to January 2025

  5. Estimate the proportion of various types of Vulvovaginal Candidiasis in gynecological outpatients in China

    Measured: From January 2024 to January 2025

  6. Evaluate neuropsychic behaviour of Vulvovaginal Candidiasis patients in gynecological outpatients nationwide

    Measured: From January 2024 to January 2025

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2024
  2. Study start1 Jan 2024 (estimated)
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06200389
Sponsor's protocol ID
MA-VVC-EI-001
Status last verified
Oct 2023
First submitted
28 Dec 2023
Last updated
11 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Vulvovaginal Candidiases, run by Beijing Tsinghua Chang Gung Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Qinping Liao (+86-13701124527, 13701124527@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composition and distribution of strains from gynecological Vulvovaginal Candidiasis outpatients in China (time frame: From January 2024 to January 2025). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.

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