Evaluating a test for bacterial vaginosis and candida vaginitis
Cobas® BV/CV Test for Use on the Cobas® 5800/6800/8800 Systems: Clinical Performance and Reproducibility
Hoffmann-La Roche · NCT06975436
This study is testing a new vaginal swab test to see if it can accurately detect bacterial vaginosis and candida vaginitis in both women with symptoms and those without.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 14 Years and up |
| Sex | Female |
| Sponsor | Hoffmann-La Roche (industry) |
| Locations | 10 sites (Los Angeles, California and 9 other locations) |
| Trial ID | NCT06975436 on ClinicalTrials.gov |
What this trial studies
This study evaluates the performance of the cobas® BV/CV test on vaginal swab samples collected from both symptomatic and asymptomatic individuals. A minimum of 500 symptomatic participants with signs of vaginitis and 100 asymptomatic participants will provide samples for analysis. The test aims to detect DNA from pathogens associated with bacterial vaginosis and candida vaginitis, comparing results with established FDA-cleared assays. The primary goal is to assess the sensitivity and specificity of the cobas® BV/CV assay.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 14 years or older with symptoms consistent with vaginitis or those who are asymptomatic and healthy.
Not a fit: Patients with conditions unrelated to bacterial vaginosis or candida vaginitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing bacterial vaginosis and candida vaginitis, leading to better treatment outcomes for patients.
How similar studies have performed: Previous studies have shown success with similar diagnostic approaches, indicating potential for effective outcomes in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion Criteria for Symptomatic Participants: * Symptomatic participants with a clinical presentation consistent with vaginitis, vaginosis, or both; symptoms may include abnormal vaginal discharge, painful or frequent urination, vaginal itching or burning or irritation, painful or uncomfortable intercourse, and/or abnormal vaginal odor. * Participants aged 14 years or older who are willing and able to provide written, informed consent; for pediatric participants, written assent and parent/legal guardian consent, as applicable by the institutional review board/ethics committee (IRB/EC). Inclusion Criteria for Asymptomatic Participants: * Apparently healthy participants aged 14 years or older who are willing and able to provide written, informed consent; for pediatric participants, written assent and parent/legal guardian consent, as applicable by the IRB/EC. Exclusion Criteria: Exclusion Criteria for Symptomatic Participants: * Participants not meeting the above described inclusion criteria will be excluded from the study. * Use of any azole-containing antimicrobial (oral or vaginal) within the 7 days prior to study enrollment. * Prior enrollment in this study. * Use of any lubricants (eg, Replens, RepHresh) within 3 days prior to sample collection * Use of douches, vaginal deodorizers, or other intravaginal products within 3 days prior to sample collection. The use of tampons or pads during menses should not be considered exclusionary criteria. * Contraindication to vaginal swab sampling. * Asymptomatic participants who do not have any signs or symptoms consistent with vaginitis, vaginosis, or both, as described above. Exclusion Criteria for Asymptomatic Participants: * Prior enrollment in this study. * Participants with a clinical presentation consistent with vaginitis, vaginosis, or both; symptoms may include abnormal vaginal discharge, painful or frequent urination, vaginal itching or burning or irritation, painful or uncomfortable intercourse, and/or abnormal vaginal odor.
Where this trial is running
Los Angeles, California and 9 other locations
- Matrix Clinical Research — Los Angeles, California, United States (RECRUITING)
- M3 Wake Research - San Diego at Convoy — San Diego, California, United States (RECRUITING)
- Red Rocks OBGYN — Lakewood, Colorado, United States (COMPLETED)
- Altus Research — Lake Worth, Florida, United States (RECRUITING)
- Washington University — Saint Louis, Missouri, United States (RECRUITING)
- Eastern Carolina Women's Center — New Bern, North Carolina, United States (RECRUITING)
- Unified Women's Clinical Research/Lyndhurst — Winston-Salem, North Carolina, United States (RECRUITING)
- Planned Parenthood Gulf Coast — Houston, Texas, United States (RECRUITING)
- Diagnostic Consultative Center "Ascendent" Ltd. — Sofia, Bulgaria (NOT_YET_RECRUITING)
- Centre Hospitalier Universitaire Vaudois (Chuv) — Lausanne, Switzerland (NOT_YET_RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bacterial Vaginosis, Candida Vaginitis