Clinical trial NCT04984460: Morphological Detection of Liquid-based Thin-layer Film-making Fungi for Fungal Vaginitis in Multiple Hospitals
Official title: A Multicenter Clinical Study on Liquid-based Morphological Detection of Fungi
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vaginitis
Keywords: Fluorescence morphological
liquid-based thin-layer film-making
Fungal vaginitis
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients with suspected fungal vaginitis.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparing the positive detection rate of 3/4 different detection methods in the first phase.
timeFrame: From Aug. 1st to Dec. 31st, 2021
measure: Calculating the proportion of the number of fungi in three different states in the map results of three/four detection methods.
timeFrame: From Aug. 1st, 2021 to Jan. 31st, 2022
measure: 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.
timeFrame: From Mar. 1, 2022 to Dec. 31st, 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Ustc
state: Anhui
city: Zhongshan
country: China
facility: Zhongshan City People's Hospital
state: Guangdong
city: Nantong
country: China
facility: The Second Affiliated Hospital of Nantong University
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Nantong Hospital Of Shanghai University
state: Jiangsu
city: Nantong
country: China
facility: Nantong Maternal and Child Health Hospital
state: Jiangsu
city: Qidong
country: China
facility: Children's Hospital of Fudan University Qidong Branch
state: Jiangsu
city: Jiujiang
country: China
facility: Jiujiang Maternal and Child Health Hospital
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health Hospital
state: Jiangxi
city: Shanghai
country: China
facility: Changning District Maternal and Child Health Care Hospital
state: Shanghai
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Yuquan Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: