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NCT06975436 · ClinicalTrials.gov registry record
Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis
A clinical trial of Bacterial Vaginosis and Candida Vaginitis, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- 738
- Enrollment target
- 10
- Study locations
NCT06975436: Completed study of Bacterial Vaginosis and Candida Vaginitis, sponsored by Hoffmann-La Roche.
NCT06975436 is a study of Bacterial Vaginosis and Candida Vaginitis that has completed, run by Hoffmann-La Roche. The registered enrollment target is 738 participants, above the 289-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (155% higher). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06975436, a study of Bacterial Vaginosis and Candida Vaginitis, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- 738 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
The sensitivity of a diagnostic test is the percentage of true positive (TP) tests out of all patients with a condition. It is calculated as follows: 100% x (TP)/(TP + false negatives (FN)). The BV test results will be compared with the patient infection status (PIS) established by using 3 Food and Drug Administration (FDA)-cleared commercial assays. The CV test results will be compared with the PIS established by using selective culture and MALDI-TOF.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST cobas® BV/CV test
- DIAGNOSTIC_TEST BD Max™ Vaginal Panel
- DIAGNOSTIC_TEST Cepheid Xpert Xpress MVP
- DIAGNOSTIC_TEST Hologic Aptima BV Assay
Study Locations (10)
California
- Matrix Clinical Research - Los Angeles
- M3 Wake Research - San Diego at Convoy - San Diego
North Carolina
- Eastern Carolina Women's Center - New Bern
- Unified Women's Clinical Research/Lyndhurst - Winston-Salem
Other
- Diagnostic Consultative Center "Ascendent" Ltd. - Sofia
- Centre Hospitalier Universitaire Vaudois (Chuv) - Lausanne
Colorado
- Red Rocks OBGYN - Lakewood
Florida
- Altus Research - Lake Worth
Missouri
- Washington University - St Louis
Texas
- Planned Parenthood Gulf Coast - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 738 participants |
| Start Date | 2024-12-30 |
| Est. Completion | 2025-06-30 |
What the finished NCT06975436 record still lists
NCT06975436 is an observational study that tracks outcomes without assigning an intervention. The registered 738 participants enrollment target is mid-sized for trials with a published cap, above the 289-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (155% higher).
The record links to 2 conditions, with Bacterial Vaginosis appearing as the primary indexed condition, and to 4 interventions - of which cobas® BV/CV test is the first listed.
NCT06975436 lists 10 locations in 7 states (California, North Carolina, Other).
Frequently Asked Questions
What is clinical trial NCT06975436 about?
NCT06975436 is a clinical study titled "Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis". 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,...
What is the current status of trial NCT06975436?
This trial is currently completed. The enrollment target is 738 participants. The study started on 2024-12-30. Estimated completion is 2025-06-30.
What conditions does trial NCT06975436 study?
This clinical trial studies the following conditions: Bacterial Vaginosis, Candida Vaginitis.
What interventions are being tested in trial NCT06975436?
The interventions under investigation include: cobas® BV/CV test (DIAGNOSTIC_TEST), BD Max™ Vaginal Panel (DIAGNOSTIC_TEST), Cepheid Xpert Xpress MVP (DIAGNOSTIC_TEST), Hologic Aptima BV Assay (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06975436?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06975436 being conducted?
This trial has 10 study locations across California, Colorado, Florida, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06975436's enrollment target sits among peer trials
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