Bacterial InfectionsLAVANCT07607470
Large Algorithm Setting and Validation Study
An observational study of Bacterial Infections and Bacterial Infections and Mycoses, run by Nanopath, Inc at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Infections, Bacterial Infections and Mycoses, Infections
- What is being tested?
- Nanopath Vaginitis Assay, BD Max™ Vaginal Panel and Cepheid Xpert® Xpress MVP
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jun 2026to Jan 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The intended use population will be up to 1000 symptomatic participants with a clinical presentation consistent with vaginitis.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
LSU-CrescentCare Sexual Health Center
New Orleans, Louisiana, 70119
Catherine Cammarata, 504-568-4132, ccamma@lsuhsc.edu
Rebecca Lillis, MD
- Recruiting
Segal Trials
North Miami, Florida, 33161
Anna Kaplan, 347-678-6542, akaplan@segaltrials.com
Steven Chavoustie, MD, FACOG, CCRP
About this study
Official title: A Non-Significant Risk Specimen Collection Study to Obtain Vaginal Swab Samples for Algorithm Development and Testing
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.
Read the detailed description
This is an observational, diagnostic study.
- Conditions
- Bacterial Infections, Bacterial Infections and Mycoses, Infections, Vaginitis, Vaginal Diseases, Genital Diseases, Female
- Being tested
- Nanopath Vaginitis Assay, BD Max™ Vaginal Panel, Cepheid Xpert® Xpress MVP, Hologic Aptima® BV Assay, Yeast Culture
- Medical subject headings
- Bacterial Infections, Bacterial Infections and Mycoses, Infections, Vaginitis, Vaginal Diseases, Genital Diseases, Female, Female Urogenital Diseases, Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanopath Vaginitis AssayDiagnostic test
Investigational Device
BD Max™ Vaginal PanelDiagnostic test
This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.
Cepheid Xpert® Xpress MVPDiagnostic test
This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.
Hologic Aptima® BV AssayDiagnostic test
This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.
Yeast CultureDiagnostic test
Culture plus use of MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization Time-of-Flight mass spectrometry) for required speciation.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Infections (BV, CV, TV) | Not described Receives: Diagnostic Test: Nanopath Vaginitis Assay; Diagnostic Test: BD Max™ Vaginal Panel; Diagnostic Test: Cepheid Xpert® Xpress MVP; Diagnostic Test: Hologic Aptima® BV Assay; Diagnostic Test: Yeast Culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Nanopath Assay for Diagnosis of Vaginal Infections
Compare the sensitivity and specificity of the Nanopath assay to NAAT and yeast culture for diagnosing vaginitis
Measured: 1 day
Secondary outcomes (1)
Equivalency of Percent Agreement Between Self-Collected and Clinician-Collected Samples Using the Nanopath Assay
Compare the performance between clinician-collected samples and self-collected samples using the Nanopath assay for diagnosing vaginitis.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start3 Jun 2026
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanopath, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607470
- Sponsor's protocol ID
- LAVA Protocol
- Acronym
- LAVA
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No