VVC Sampling Study for Analysis Validation

Completed

• Conditions: Vulvovaginal Candidiasis

• Registration Number: NCT05327192
• Lead Sponsor: Gedea Biotech AB

Brief Summary

This is a biomarker multi-centre study to validate an extraction method of fungal and bacterial DNA extracted from vaginal swabs from adult women with confirmed VVC.

The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms.

Vaginal samples will be examined under a microscope for yeast forms (hyphae or pseudohyphae) or budding yeast. If the Investigator assesses that the patient has VVC, based on examination and the potassium hydroxide (KOH) test, two vaginal secretion samples will be collected by a vaginal swab. One sample will be cultured to verify the presence of Candida and the other will be used for sequencing analysis of the vaginal microbiome.

Samples from a total of 10 women are planned to be taken.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-14
• Study Start: 2022-05-12
• Primary Completion: 2022-07-06
• Study Completion: 2022-07-06
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

1. Adult women aged 18 years or older

2. Diagnosis of VVC, defined as having a white or creamy vaginal discharge plus the following findings:

   1. At least 2 of the following signs and symptoms of VVC that are characterized as at least moderate: itching, burning, irritation, edema, redness, or excoriation.
   2. Potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.

3. Having decisional capacity and providing written informed consent

4. Signed informed consent and willing and able to comply with all study requirements

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between vaginal sample DNA sequencing and VVC confirmed by clinical diagnosis and culture.	1 day

Trial Locations

Locations (2)

Research and Development Department, Berkshire Healthcare NHS Foundation Trust; 🇬🇧 Slough, United Kingdom

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, United Kingdom