Managing Infectious Vulvovaginitis for Precancerous Conditions of the Vulva

Overseen By Amanda Urban

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Virginia

Must not be taking: Antibiotics, Corticosteroids

Disqualifiers: Pregnancy, Immunosuppression, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

91 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how common vaginal infections, such as bacterial vaginosis, trichomonas, and candida, affect surgery outcomes for non-cancerous vulvar conditions. Researchers will determine if these infections cause problems with wound healing after surgery. They will use a Vaginitis Panel (a swab test) on the day of surgery and follow up a few weeks later. Women with confirmed non-cancerous vulvar conditions who plan to undergo specific types of surgery are good candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to important research that may improve surgical outcomes for others in the future.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used antibiotics recently (within the last 3 weeks or 5.5 times the half-life of the antibiotic). If you are on chronic treatment with corticosteroids or other immunosuppressive agents, you may not be eligible to participate.

What prior data suggests that the Vaginitis Panel is safe?

Research has shown that the Vaginitis Panel is a test used to detect infections such as bacterial vaginosis (BV), yeast infections, and trichomonas. It serves as a diagnostic tool, not a treatment. The test is generally safe and involves taking a swab, similar to a routine medical test.

No known side effects are associated with the Vaginitis Panel. The procedure is simple, akin to other swab tests conducted in medical settings. These tests assist doctors in identifying the cause of symptoms like itching, soreness, or unusual discharge.

As the Vaginitis Panel is a test, not a treatment, it lacks the risks associated with medications or surgeries. It aids in diagnosing the condition so doctors can recommend the best treatment for any infections detected. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Vaginitis Panel is unique because it uses a comprehensive diagnostic approach to identify and manage infections like bacterial vaginosis (BV), candida, and trichomonas, which are linked to vulvar precancerous conditions. Unlike traditional treatments that might focus on just one infection, this panel provides a more holistic evaluation, potentially leading to more targeted and effective treatment strategies. Researchers are excited because this could streamline diagnosis and treatment, leading to better management of these infections and possibly reducing the progression to more serious conditions.

What evidence suggests that the Vaginitis Panel is effective for managing infectious vulvovaginitis in precancerous conditions of the vulva?

Research has shown that the Vaginitis Panel, used in this trial, effectively diagnoses infections such as bacterial vaginosis (BV), trichomonas, and yeast infections (candida). One study found that a similar test, the Vaginal Panel Real-Time PCR kit, performed well compared to standard tests for diagnosing these infections, accurately detecting them. Early identification can help manage symptoms like itching and soreness. This is particularly important for individuals with non-cancerous vulvar conditions who might require surgery, as it helps reduce the risk of complications like wound infections. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with non-cancerous vulvar conditions needing surgery in central VA. Participants must not be pregnant, recently on antibiotics, have a history of cancer treatments within 3 years, or have immune system issues. They should be able to consent and not have uncontrolled diabetes or severe infections.

Inclusion Criteria

I am scheduled for a lumpectomy or partial mastectomy.

You have provided written consent to proceed with any procedures required for the protocol.

My vulvar condition is confirmed not to be cancer.

Exclusion Criteria

I am unable to understand and agree to the study's procedures and risks.

I am not pregnant or nursing.

I haven't taken antibiotics in the last 3 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Testing

Vulvovaginal swab collected preoperatively on the day of surgery to test for bacterial vaginosis, trichomonas, and candida

1 day

1 visit (in-person)

Postoperative Follow-up

Outcome evaluated by phone call at 1 week after surgery and physical exam at postoperative visit between 4-6 weeks

6 weeks

1 phone call, 1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vaginitis Panel

Trial Overview The study aims to measure the rate of infectious vulvovaginitis and its correlation with wound complications after surgical excision for premalignant lesions. Patients will be swabbed preoperatively to test for common causes like BV, trichomonas, and candida.

How Is the Trial Designed?

Group I: Positive Perioperative Vaginitis Experimental Treatment 1 Intervention

Participants who test positive for BV, candida, and/or trichomonas on perioperative vaginitis swab.

Vaginitis Panel is already approved in United States, European Union for the following indications:

Approved in United States as Vaginitis Panel for:

• Diagnosis of bacterial vaginosis (BV)
• Diagnosis of trichomonas
• Diagnosis of candida

Approved in European Union as Vaginitis Panel for:

• Diagnosis of vaginal infections
• Screening for sexually transmitted infections

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

In a study of 271 women aged 25, the HPV-16/18 AS04-adjuvated vaccine was found to be safe, with no severe adverse events reported, and the most common side effects were injection site pain (83.4%), local swelling (20.8%), and fever (14.6%).

The safety profile of the vaccine in adult women was similar to that observed in preadolescent girls, although adults reported higher frequencies of fever and local pain, indicating that while the vaccine is generally well-tolerated, adults may experience slightly more discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of bivalent human papillomavirus (HPV) vaccine safety and tolerability in a sample of 25 year old Tuscan women. Levi, M., Bonanni, P., Burroni, E., et al.[2022]

In a study of 489 participants, the vaginal panel assay showed significantly better diagnostic accuracy for bacterial vaginosis and Trichomonas vaginalis compared to clinical assessments, with positive agreement rates of 57.9% and 28.0%, respectively.

The clinical diagnosis missed a substantial number of cases, with 65% of bacterial vaginosis and 44% of vulvovaginal candidiasis cases identified by the assay going untreated due to negative clinical diagnoses, highlighting the potential of the assay to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of a Vaginal Panel Assay Compared With the Clinical Diagnosis of Vaginitis. Broache, M., Cammarata, CL., Stonebraker, E., et al.[2022]

The Xpert Xpress MVP test showed high accuracy in diagnosing vaginitis/vaginosis, with positive agreement rates between 93.6% and 99.0% and negative agreement rates between 92.1% and 99.8% for both clinician-collected and self-collected samples.

Conducted across 12 diverse clinical sites in the U.S., this study suggests that the MVP test could be a reliable diagnostic tool in both laboratory and point-of-care settings for patients with symptoms of vaginitis/vaginosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of a New Molecular Test for the Detection of Organisms Causing Vaginitis and Vaginosis. Lillis, RA., Parker, RL., Ackerman, R., et al.[2023]

Women diagnosed with vulvovaginitis using amplified molecular probe testing (AMP) had significantly lower healthcare utilization and costs compared to those diagnosed with non-amplified molecular probe testing (NAMP), with fewer outpatient visits and lower prescription medication use.

Among pregnant women, AMP testing was associated with a 12% reduction in the risk of preterm labor or delivery, highlighting its potential to improve health outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health care utilization and costs following amplified versus non-amplified molecular probe testing for symptomatic patients with suspected vulvovaginitis: a US commercial payer population. Ackerman, SJ., Knight, T., Wahl, PM., et al.[2022]

In a study of 347 women in India, bacterial vaginosis (BV) was found to have a prevalence of 45.1%, highlighting a significant public health concern in reproductive-age women.

The OSOM BVBlue test showed good specificity (92.7%) but poor sensitivity (38.1%) compared to the Nugent score, indicating that while it can accurately identify those without BV, it may miss many cases, suggesting a need for improved diagnostic methods in resource-poor settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of BVBlue rapid test in detecting bacterial vaginosis among women in Mysore, India. Madhivanan, P., Krupp, K., Li, T., et al.[2021]

The Affirm VPIII molecular test was found to be significantly more sensitive than the routine Pap test in detecting Candida species, Trichomonas vaginalis, and Gardnerella vaginalis in a study of 431 women aged 17 to 79.

While the Pap test identified 13.9% of patients with bacterial vaginosis and candidiasis, the Affirm VPIII assay detected 42.5% for Gardnerella, 16.2% for Candida, and 2.3% for Trichomonas, highlighting its superior diagnostic capability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Affirm VPIII and Papanicolaou tests in the detection of infectious vaginitis. Levi, AW., Harigopal, M., Hui, P., et al.[2013]

The BD Affirm VPIII test showed lower sensitivity and specificity compared to nucleic acid amplification (NAA) tests for diagnosing bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC), with BV-PCR achieving 96.9% sensitivity and 92.6% specificity, while Affirm VPIII had 90.1% sensitivity and 67.6% specificity.

For trichomoniasis, the GenProbe Aptima test demonstrated significantly higher sensitivity (98.1%) compared to Affirm VPIII (46.3%), indicating that NAA tests are generally more reliable for diagnosing vaginitis than the nonamplified BD Affirm VPIII system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of nucleic acid amplification assays with BD affirm VPIII for diagnosis of vaginitis in symptomatic women. Cartwright, CP., Lembke, BD., Ramachandran, K., et al.[2022]

Genital HPV infection is the most common sexually transmitted infection, contributing to nearly all cervical cancers and a significant number of other anogenital and oropharyngeal cancers, highlighting the importance of prevention through vaccination.

Two effective prophylactic HPV vaccines, Gardasil and Cervarix, induce protective immunity and are most effective when administered before sexual activity, significantly reducing the risk of HPV-related cancers and diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papilloma virus vaccines: Current scenario. Pandhi, D., Sonthalia, S.[2022]

Cervarix, a vaccine targeting HPV types 16 and 18, demonstrated high efficacy in preventing high-grade cervical lesions and cervical cancer in over 19,000 women aged 15-25, with a follow-up of at least 5.5 years.

The vaccine induced a stronger immune response in younger girls (10-14 years) compared to older women (26-55 years), and was generally well tolerated, with injection-site reactions being the most common side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus types 16 and 18 vaccine (recombinant, AS04 adjuvanted, adsorbed) [Cervarix]. Keam, SJ., Harper, DM.[2021]

A study involving 4,643 participants evaluated the safety and tolerability of the Cervarix vaccine in Italy, finding no serious adverse events and mostly mild reactions such as pain at the injection site and fatigue.

The vaccine demonstrated better tolerability compared to some clinical studies, with most reactions being of negligible intensity and duration, suggesting that real-world vaccination experiences may differ from controlled trial settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of bivalent HPV vaccine: an Italian post-licensure study. Gasparini, R., Bonanni, P., Levi, M., et al.[2019]

The Affirm VPIII Microbial Identification Test demonstrated comparable detection rates for Gardnerella and Candida infections when compared to standard diagnostic methods, with sensitivity of 75.0% for Gardnerella and 82.76% for Candida.

This test offers a rapid diagnostic option for physicians treating vulvovaginitis, allowing for timely diagnosis and treatment at the point of care, which is particularly beneficial for the 195 women studied, most of whom were symptomatic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Affirm VPIII microbial identification test can be used to detect gardnerella vaginalis, Candida albicans and trichomonas vaginalis microbial infections in Korean women. Byun, SW., Park, YJ., Hur, SY.[2020]

The post-licensure safety profile of HPV vaccines Gardasil and Cervarix was evaluated using data from three sources, including VigiBase and VAERS, confirming that the reported adverse events align with existing safety data.

The analysis showed that the safety profiles of both vaccines are consistent with the information provided in their Summary of Product Characteristics (SPC), indicating that they are safe for public use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. Labadie, J.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12167788/

Real-world clinical burden of patients presenting with ... A total of 18,745,351 people were documented with vaginitis symptoms or vaginitis in the study selection window, of which 4,000,615 patients met ...

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0313414

Evaluation of the Vaginal Panel Realtime PCR kit (Vircell, SL ... Our results demonstrate that the Vaginal Panel Real-Time PCR kit shows optimal concordance with routinely used diagnostics for diagnosing vaginitis.

3. arupconsult.com arupconsult.com/ati/vaginitis-pathogens-molecular-testing-panel

Vaginitis Panel by TMA | Test Fact Sheet Typical symptoms of infectious vaginitis include pruritus, vaginal soreness, dyspareunia, external dysuria, odor, and abnormal vaginal discharge.

4. aetna.com aetna.com/cpb/medical/data/600_699/0643.html

Diagnosis of Vaginitis - Medical Clinical Policy Bulletins By comparison, the sensitivity and specificity of the DNA probe test for vulvo-vaginal candidiasis was 75.0 % and 95.7 %, vaginal trichomoniasis was 86.5 % and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7591372/

Improving the Diagnosis of Vulvovaginitis: Perspectives to ... Newer molecular tests, which are both more sensitive and specific, have introduced the potential to transform the diagnosis of vaginitis.

6. questhealth.com questhealth.com/product/vaginitis-test-panel-13716M.html?srsltid=AfmBOoqCZLs1qZedNbeaFVjUCTv2WFgGdz7x_AwAJUqRPtCCtHeQiB07

Vaginitis Panel Test - Quest Diagnostics Buy a vaginitis panel test online to help identify BV, CV, and trichomoniasis infections. Get vaginitis testing at a nearby location - no doctor's visit ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06070454?cond=Vaginitis&aggFilters=status:rec&viewType=Table&rank=7

Prospective Evaluation of Infectious Vulvovaginitis on ... To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision ...

8. news.bd.com news.bd.com/2022-01-26-New-Study-Finds-Up-to-One-Third-of-Women-Receive-Clinical-Misdiagnosis-of-Vaginitis

New Study Finds Up to One-Third of Women Receive ... Study uses real-world data to demonstrate the effectiveness of vaginal panel performed on the BD MAX™ System compared to clinicians' ...

9. uptodate.com uptodate.com/contents/vaginitis-in-adults-and-adolescents-initial-evaluation

Vaginitis in adults and adolescents: Initial evaluation - UpToDate Symptoms include abnormal vaginal discharge, odor, pruritus, and/or discomfort. The initial evaluation typically consists of a history, physical ...