NCT06200389

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

January 11, 2024

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

December 28, 2023

Last Update Submit

December 28, 2023

Conditions

Vulvovaginal Candidiases

Outcome Measures

Primary Outcomes (1)

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

    From January 2024 to January 2025

Secondary Outcomes (6)

  • Evaluate the sensitivity and resistance of commonly used antifungal treatments

    From January 2024 to January 2025

  • Evaluate risk factors of gynecological Vulvovaginal Candidiasis outpatients in China

    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)

    From January 2024 to January 2025

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

    From January 2024 to January 2025

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

    From January 2024 to January 2025

  • +1 more secondary outcomes

Interventions

microbiology testingDIAGNOSTIC_TEST

Vulvovaginal Candidiases patients diagnosed by microbiology testing can be included

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with Vulvovaginal Candidiasis symptomatology and positive culture

You may qualify if:

  • 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

You may not qualify if:

  • Antifungal medication was used within 7 days (oral or topical)
  • With contraindications of vaginal sampling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fungal culture and drug sensitivity detection of vaginal secretions

Central Study Contacts

Qinping Liao

CONTACT

+86-1370112452713701124527@163.com

Lei Zhang

CONTACT

+86-1860113045918601130459@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 11, 2024

Study Start

January 1, 2024

Primary Completion

January 1, 2025

Study Completion

July 1, 2025

Last Updated

January 11, 2024

Record last verified: 2023-10