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.
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.
- Conditions
- Vulvovaginal Candidiases
- 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.
Composition and distribution of strains from gynecological Vulvovaginal Candidiasis outpatients in China
Measured: From January 2024 to January 2025
Secondary outcomes (6)
Evaluate the sensitivity and resistance of commonly used antifungal treatments
Measured: From January 2024 to January 2025
Evaluate risk factors of gynecological Vulvovaginal Candidiasis outpatients in China
Measured: From January 2024 to January 2025
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
Consistency analysis of clinical and microbiological diagnosis from gynecological Vulvovaginal Candidiasis outpatients in China
Measured: From January 2024 to January 2025
Estimate the proportion of various types of Vulvovaginal Candidiasis in gynecological outpatients in China
Measured: From January 2024 to January 2025
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.
- First posted11 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal CandidiasesStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of Vulvovaginal Candidiases Strain Types and Risk Factors Among Gynecological Outpatients From Multiple Sites in China
- ClinicalTrials.gov ID
- NCT06200389
- Acronym / sponsor ID
- MA-VVC-EI-001
- Conditions
- Vulvovaginal Candidiases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with Vulvovaginal Candidiasis symptomatology and positive culture
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Antifungal medication was used within 7 days (oral or topical)
- With contraindications of vaginal sampling
- Other conditions deemed unsuitable for inclusion by clinicians
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microbiology testingVulvovaginal Candidiases patients diagnosed by microbiology testing can be included | Diagnostic test | – |
Primary outcome
Composition and distribution of strains from gynecological Vulvovaginal Candidiasis outpatients in China
Time frame: From January 2024 to January 2025
6 secondary outcomes
Evaluate the sensitivity and resistance of commonly used antifungal treatments
Time frame: From January 2024 to January 2025
Evaluate risk factors of gynecological Vulvovaginal Candidiasis outpatients in China
Time frame: From January 2024 to January 2025
Estimate the proportion of different ages of gynecological Vulvovaginal Candidiasis outpatients in China (Childbearing age and non-childbearing age)
Time frame: From January 2024 to January 2025
Consistency analysis of clinical and microbiological diagnosis from gynecological Vulvovaginal Candidiasis outpatients in China
Time frame: From January 2024 to January 2025
Estimate the proportion of various types of Vulvovaginal Candidiasis in gynecological outpatients in China
Time frame: From January 2024 to January 2025
Evaluate neuropsychic behaviour of Vulvovaginal Candidiasis patients in gynecological outpatients nationwide
Time frame: From January 2024 to January 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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.