Status:
COMPLETED
Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Roche Molecular Systems
Conditions:
Bacterial Vaginosis
Candida Vaginitis
Eligibility:
FEMALE
14+ years
Brief Summary
In the clinical performance part of this study, prospectively acquired clinician-collected and clinician-instructed, self-collected vaginal swab specimens collected in cobas® PCR Media will be taken f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
738 Patients enrolled
Trial Details
Trial ID
NCT06975436
Start Date
December 30 2024
End Date
June 30 2025
Last Update
July 14 2025
Active Locations (10)
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1
Matrix Clinical Research
Los Angeles, California, United States, 90057-4103
2
M3 Wake Research - San Diego at Convoy
San Diego, California, United States, 92111
3
Red Rocks OBGYN
Lakewood, Colorado, United States, 80228
4
Altus Research
Lake Worth, Florida, United States, 33461