Morphological Detection of Liquid-based Thin-layer Film-making Fungi for Fungal Vaginitis in Multiple Hospitals

Study Overview
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Brief Summary
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The purpose of this study is to compare the results of different detection methods for non-gestational fungal vaginitis (VVC), and to evaluate the significance of different fungal states in the results for diagnosis and treatment.

Detailed Description
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The study was divided into two phases: in the first phase, the vaginal secretions of 1000 enrolled patients with fungal vaginitis were detected with 3/4 different methods, and the sensitivity, specificity and consistency of these methods were compared; In the second stage, 1000 patients from the first stage were selected to meet the follow-up stage and divided into two groups. The test of Follow-up fungal culture and fluorescence morphological detection of liquid-based thin-layer film-making fungi were performed periodically. At last, the applicant will analyze the data, write the paper and publish the article.

Official Title
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A Multicenter Clinical Study on Liquid-based Morphological Detection of Fungi

Conditions
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Vaginitis

Intervention / Treatment
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* Diagnostic Test: Fluorescence morphological detection of liquid-based thin-layer film-making fungi


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Samples from outpatient or inpatient clinics to be tested for fungal vaginitis. 2. A sample of one or more of the following characteristics. 2.1 Symptoms: vulva pruritus, burning pain, but also accompanied by pain in urine and sexual pain and other symptoms; Leucorrhea increased. 2.2 Physical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd. 3. The samples are vaginal secretions from the female body. Each sample should be the amount on one swab. 4. The sample is not in menstrual period. 5. The sample subjects did not have vaginal irrigation, medication or sexual intercourse within 3 days. Exclusion Criteria: 1. Cases with incomplete specimen collection; 2. Mixed vaginitis cases; 3. Abscission cases with incomplete follow-up.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| life-style counseling<br>A sample of one or more of the following characteristics. Symptoms: vulva pruritus, burning pain, but also accompanied by pain in urine and sexual pain and other symptoms; Leucorrhea increased. Physical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd. | Diagnostic Test: Fluorescence morphological detection of liquid-based thin-layer film-making fungi<br>* Samples from outpatient or inpatient clinics to be tested for fungal vaginitis. A sample of one or more of the following characteristics. Symptoms: vulva pruritus, burning pain, but also accompanied by pain in urine and sexual pain and other symptoms; Leucorrhea increased. Physical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd. Samples are human vaginal secretions. Each sample should be the amount on one swab. The sample is not in menstrual period. The sample subjects did not have vaginal irrigation, medication or sexual intercourse within 3 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the positive detection rate of 3/4 different detection methods in the first phase. | The positive coincidence rate (sensitivity), negative coincidence rate (specificity) and total coincidence rate (consistency) was compared, according to the P<0.05 was used to determine whether it was statistically significant. | From Aug. 1st to Dec. 31st, 2021 | 
| Calculating the proportion of the number of fungi in three different states in the map results of three/four detection methods. | Counting The number and proportion of mycelia, spores and blastospores, especially the percentage of cases of single spore (+) in all cases of fungus (+). | From Aug. 1st, 2021 to Jan. 31st, 2022 | 
| Counting the positive numbers of 4 or 6 liquid-based thin-layer fungal fluorescence morphological tests and fungal culture in the Stage 2_follow-up stage. | the positive coincidence rate (sensitivity), negative coincidence rate (specificity) of 4 or 6 liquid-based thin-layer fungal fluorescence morphological tests | From Mar. 1, 2022 to Dec. 31st, 2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluorescence morphological, liquid-based thin-layer film-making, Fungal vaginitis