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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Significant Risk Specimen Collection Study to Obtain Vaginal Swab Samples for Algorithm Development and Testing
- ClinicalTrials.gov ID
- NCT07607470
- Acronym / sponsor ID
- LAVA / LAVA Protocol
- Conditions
- Bacterial Infections, Bacterial Infections and Mycoses, Infections, Vaginitis, Vaginal Diseases, Genital Diseases, Female
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nanopath, IncIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an observational, diagnostic study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaginal Infections (BV, CV, TV) | – | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The intended use population will be up to 1000 symptomatic participants with a clinical presentation consistent with vaginitis.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanopath Vaginitis AssayInvestigational Device | Diagnostic test | Vaginal Infections (BV, CV, TV) |
| BD Max™ Vaginal PanelThis is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study. | Diagnostic test | Vaginal Infections (BV, CV, TV) |
| Cepheid Xpert® Xpress MVPThis is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study. | Diagnostic test | Vaginal Infections (BV, CV, TV) |
| Hologic Aptima® BV AssayThis is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study. | Diagnostic test | Vaginal Infections (BV, CV, TV) |
| Yeast CultureCulture plus use of MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization Time-of-Flight mass spectrometry) for required speciation. | Diagnostic test | Vaginal Infections (BV, CV, TV) |
Primary outcome
Accuracy of Nanopath Assay for Diagnosis of Vaginal Infections
Time frame: 1 day
Compare the sensitivity and specificity of the Nanopath assay to NAAT and yeast culture for diagnosing vaginitis
1 secondary outcome
Equivalency of Percent Agreement Between Self-Collected and Clinician-Collected Samples Using the Nanopath Assay
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infections and Bacterial Infections and Mycoses, run by Nanopath, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Nanopath Assay for Diagnosis of Vaginal Infections (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.