Large Algorithm Setting and Validation Study
Recruiting now
Conditions studied: Bacterial Infections, Bacterial Infections and Mycoses, Infections, Vaginitis, Vaginal Diseases, Genital Diseases, Female, Female Urogenital Diseases, Urogenital Disease, Candidiasis, Mycoses, Vulvovaginitis, Vulvar Diseases, Vaginosis, Bacterial
In brief
In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a bacterial vaginosis diagnostic algorithm and evaluate the performance of the Nanopath assay. The Nanopath assay is an amplification-free molecular test that detects pathogens associated with vaginitis. The performance of the Nanopath assay will be assessed by comparing Nanopath assay results to previously FDA-cleared commercial tests and yeast culture.
Key facts
- Study ID
- NCT07607470
- Run by
- Nanopath, Inc
- People needed
- 1000
- Starts
- 2026-06-03
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Biologically female participants, ≥ 18 years of age, with at least one of the following symptoms of vaginitis:
- Abnormal vaginal discharge
- Vaginal or vulvar itching, burning, or irritation
- Painful or uncomfortable intercourse
- Vaginal odor
- Painful or frequent urination
You may not qualify if…
- Participants who do not meet the above-described inclusion criteria will be excluded from the study.
- Previously enrolled in this study
- Contraindication to vaginal swab sampling
Where it is running
- Segal Trials — North Miami, Florida, United States (enrolling)
- LSU-CrescentCare Sexual Health Center — New Orleans, Louisiana, United States (enrolling)
Full record on ClinicalTrials.gov
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