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Diagnostic Test

Point of Care Test for Vaginal Infections (PAT Trial)

N/A

Recruiting

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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 14 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants prescribed appropriate treatment

Secondary study objectives

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 study objectives

Number of healthcare providers that are satisfied with Xpert® Xpress MVP test

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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