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Diagnostic Test

Point of Care Test for Vaginal Infections (PAT Trial)

N/A
Waitlist Available
Led By Sharon L Hillier, PhD
Research Sponsored by Sharon L Hillier
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 14 months
Awards & highlights

Summary

This trial will enroll individuals with vaginal complaints to compare the diagnosis and treatment using standard care methods to using a Food and Drug Administration-approved point of care test for diagnosing vaginitis. Participants will be

Who is the study for?
This trial is for individuals experiencing symptoms of vaginal infections such as Bacterial Vaginosis, Trichomoniasis, Yeast infection, or Vaginitis. Participants will be assessed using either usual care methods or a new point-of-care test to diagnose and treat their condition.
What is being tested?
The study compares the effectiveness of standard diagnostic practices (usual care) with a new FDA-approved point-of-care test called Xpert® Xpress MVP in diagnosing and treating vaginal infections. Patients are randomly assigned to one of these two approaches.
What are the potential side effects?
There may not be direct side effects from participating in this trial since it involves diagnostic tests rather than medications. However, there could be discomfort or other typical risks associated with medical testing procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 14 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 14 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants prescribed appropriate treatment
Secondary outcome measures
Number of accurate BD AffirmTM VPIII test results
Number of participants that are satisfied with their office visit
Number of participants that receive correct diagnosis of vaginitis
+1 more
Other outcome measures
Number of healthcare providers that are satisfied with Xpert® Xpress MVP test

Trial Design

2Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment1 Intervention
Vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit
Group II: Same Day ResultsExperimental Treatment1 Intervention
the Xpert® Xpress MVP test will be run in real time as a point of care test at the time of the office visit and the results will be made available to the provider in approximately one hour. Providers will be asked to use the MVP test result for diagnosis and treatment of the participant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Usual Care
1990
Completed Phase 4
~7700

Find a Location

Who is running the clinical trial?

Sharon L HillierLead Sponsor
CepheidIndustry Sponsor
20 Previous Clinical Trials
8,718 Total Patients Enrolled
Sharon L Hillier, PhDPrincipal InvestigatorUniversity of Pittsburgh
11 Previous Clinical Trials
2,233 Total Patients Enrolled
1 Trials studying Vaginitis
299 Patients Enrolled for Vaginitis
~233 spots leftby Jun 2025
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