NCT04984460

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Affiliated Hospital of Nantong University · Academic / Other
• Sex: Female
• Age: 14 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vaginitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Fluorescence morphological detection of liquid-based thin-layer film-making fungi	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.

Timeline

• Start date: 2021-07-09
• Primary completion: 2022-12-31
• Completion: 2023-04-01
• First posted: 2021-07-30
• Last updated: 2021-07-30

Locations

10 sites across 1 country: China