Clinical trial NCT06975436: Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis
Official title: Cobas® BV/CV Test for Use on the Cobas® 5800/6800/8800 Systems: Clinical Performance and Reproducibility
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bacterial Vaginosis
Candida Vaginitis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Roche Molecular Systems
First posted: 2025-05-16
Enrollment: 600
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The intended use population will be a minimum of 500 symptomatic participants with a clinical presentation consistent with vaginitis, vaginosis, or both. A population of a minimum of 100 asymptomatic participants will also be included.

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 from a minimum of 500 symptomatic individuals with a clinical presentation consistent with vaginitis, vaginosis, or both. Additionally, a minimum of 100 asymptomatic individuals will also be enrolled in the study. The cobas® BV/CV assay amplifies and detects the deoxyribonucleic acid (DNA) of pathogens associated with bacterial vaginosis (BV) and candida vaginitis (CV). The BV results will be compared with the patient infection status (PIS) established by using 3 Food and Drug Administration (FDA)-cleared commercial assays, and the CV results will be compared with the PIS established with the use of culture plus MALDI-TOF (matrix-assisted laser desorption/ionization time-of-flight).

The primary objective of the clinical performance study is to evaluate the performance (sensitivity and specificity) of cobas® BV/CV to determine the presence of BV and/or CV in the intended use patient population when being tested on cobas® 6800/8800 systems. The secondary objective is to evaluate the equivalency of cobas® BV/CV between the cobas® 5800 system and cobas® 6800/8800 systems.


Eligibility 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.

Primary outcomes:
measure: Clinical Sensitivity of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status
timeFrame: Day 1
measure: Clinical Specificity of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status
timeFrame: Day 1
measure: Positive Predictive Value of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status
timeFrame: Day 1
measure: Negative Predictive Value of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status
timeFrame: Day 1
Secondary outcomes:
measure: Equivalency of the cobas® 5800 System and the cobas® 6800/8800 Systems: Clinical Sensitivity of the cobas® BV/CV Test for Detecting the Presence of BV and/or CV
timeFrame: Day 1
measure: Equivalency Between the cobas® 5800 System and the cobas® 6800/8800 Systems: Clinical Specificity of the cobas® BV/CV Test for Detecting the Presence of BV and/or CV
timeFrame: Day 1
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Matrix Clinical Research
state: California
city: San Diego
country: United States
facility: M3 Wake Research - San Diego at Convoy
state: California
city: Lakewood
country: United States
facility: Red Rocks OBGYN
state: Colorado
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New Bern
country: United States
facility: Eastern Carolina Women's Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Research/Lyndhurst
state: North Carolina
city: Houston
country: United States
facility: Planned Parenthood Gulf Coast
state: Texas
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center "Ascendent" Ltd.
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (Chuv)
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: