A Multicenter Clinical Study on Liquid-based Morphological Detection of Fungi
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 10
- 主要终点
- Calculating the proportion of the number of fungi in three different states in the map results of three/four detection methods.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Samples from outpatient or inpatient clinics to be tested for fungal vaginitis.
- •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.
- •The samples are vaginal secretions from the female body. 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.
排除标准
- •Cases with incomplete specimen collection;
- •Mixed vaginitis cases;
- •Abscission cases with incomplete follow-up.
结局指标
主要结局
Calculating the proportion of the number of fungi in three different states in the map results of three/four detection methods.
时间窗: From Aug. 1st, 2021 to Jan. 31st, 2022
Counting The number and proportion of mycelia, spores and blastospores, especially the percentage of cases of single spore (+) in all cases of fungus (+).
Comparing the positive detection rate of 3/4 different detection methods in the first phase.
时间窗: From Aug. 1st to Dec. 31st, 2021
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.
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.
时间窗: From Mar. 1, 2022 to Dec. 31st, 2022
the positive coincidence rate (sensitivity), negative coincidence rate (specificity) of 4 or 6 liquid-based thin-layer fungal fluorescence morphological tests
次要结局
未报告次要终点
研究者
Yuquan Zhang
Director of Obstetrics and Gynaecology
Affiliated Hospital of Nantong University