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

Vaginitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04984460
• Other study ID #: AHNantongU_YEZH_NTFS_V1.0
• Status: Enrolling by invitation
• Start date: July 9, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: July 2021
• Source: Affiliated Hospital of Nantong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: April 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vaginitis

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Ustc	Hefei	Anhui
China	Jiujiang Maternal and Child Health Hospital	Jiujiang	Jiangxi
China	Jiangxi Maternal and Child Health Hospital	Nanchang	Jiangxi
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Affiliated Nantong Hospital Of Shanghai University	Nantong	Jiangsu
China	Nantong Maternal and Child Health Hospital	Nantong	Jiangsu
China	The Second Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Children's Hospital of Fudan University Qidong Branch	Qidong	Jiangsu
China	Changning District Maternal and Child Health Care Hospital	Shanghai	Shanghai
China	Zhongshan City People's Hospital	Zhongshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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