Large Algorithm Setting and Validation Study
Recruiting
Observational Study
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Observational
- Participants needed
- 1,000 (estimated)
- Sponsor
- Nanopath, Inc · Industry
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About This Trial
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 ass…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
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
…
Contacts
No contact information available.