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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Vaginitis
• Intervention / Treatment: Diagnostic test: Fluorescence morphological detection of liquid-based thin-layer film-making fungi

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230031
      • The First Affiliated hospital of USTC
  • Guangdong
    • Zhongshan, Guangdong, China
      • Zhongshan City People's Hospital
  • Jiangsu
    • Nantong, Jiangsu, China, 226001
      • The Second Affiliated Hospital of Nantong University
    • Nantong, Jiangsu, China, 226006
      • Affiliated Hospital of Nantong University
    • Nantong, Jiangsu, China
      • Affiliated Nantong Hospital Of Shanghai University
    • Nantong, Jiangsu, China
      • Nantong Maternal and Child Health Hospital
    • Qidong, Jiangsu, China
      • Children's Hospital of Fudan University Qidong Branch
  • Jiangxi
    • Jiujiang, Jiangxi, China
      • Jiujiang Maternal and Child Health Hospital
    • Nanchang, Jiangxi, China, 330006
      • Jiangxi Maternal and Child Health Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200051
      • Changning District Maternal and Child Health Care Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Female patients with suspected fungal vaginitis.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

life-style counseling; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Investigators: Principal Investigator: Yuquan Zhang, Doctor, Affiliated Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): July 30, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Fluorescence morphological; liquid-based thin-layer film-making; Fungal vaginitis
• Additional Relevant MeSH Terms: Vaginal Diseases; Vaginitis
• Other Study ID Numbers: AHNantongU_YEZH_NTFS_V1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not planning sharing at present.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No