Vaginitis Diagnostic Algorithm Pilot Using Nanopath and Other Tests

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects clinician- and self-collected vaginal swabs from up to 1,000 individuals with vaginitis symptoms to develop and validate a bacterial vaginosis diagnostic algorithm. It compares the Nanopath assay, an amplification-free molecular test, against FDA-cleared commercial tests and yeast culture to gauge performance. The study is diagnostic in nature and does not involve an interventional treatment. It aims to determine how well Nanopath identifies pathogens associated with vaginitis across diverse clinical settings. Participating sites include Segal Trials in North Miami and LSU-CrescentCare in New Orleans.

Why it matters

Who can join: the full rules

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

Exclusion Criteria:

* 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's running

• Segal Trials
  North Miami, Florida, United States Recruiting
• LSU-CrescentCare Sexual Health Center
  New Orleans, Louisiana, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.