Status:
COMPLETED
VVC Sampling Study for Analysis Validation
Lead Sponsor:
Gedea Biotech AB
Conditions:
Vulvovaginal Candidiasis
Eligibility:
FEMALE
18+ years
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...
Eligibility Criteria
Inclusion
- Adult women aged 18 years or older
- Diagnosis of VVC, defined as having a white or creamy vaginal discharge plus the following findings:
- 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.
- Potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.
- Having decisional capacity and providing written informed consent
- Signed informed consent and willing and able to comply with all study requirements
Exclusion
- None
Key Trial Info
Start Date :
May 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 6 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05327192
Start Date
May 12 2022
End Date
July 6 2022
Last Update
August 18 2022
Active Locations (2)
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1
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG5 1PB
2
Research and Development Department, Berkshire Healthcare NHS Foundation Trust
Slough, United Kingdom