- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02203942
Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis (VAST)
Comparing NAAT Testing to Standard Methods in Diagnosis of Vaginal Infections in the General Gynecology and Vulvovaginal Referral Offices.
Vaginitis is the most common condition encountered in the gynecologist's office and is most commonly caused by bacerial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV). Establishing the correct etiology of symptomatic vaginitis can be challenging, and the evaluation of vaginitis by physicians is often substandard.
The investigators will determine whether NAAT testing will improve the diagnosis of vaginal infections including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV).
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Magee-Womens Hospital of UPMC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female participants aged 18 and older
Based on symptoms:
- Symptomatic patients: with symptoms of vaginitis that include abnormal discharge, malodor, itching, irritation and / or discomfort
- Asymptomatic controls: no vulvovaginal symptoms
- Willing to provide written informed consent for participation in this study
Exclusion Criteria:
- Use of oral antibiotics in the past 14 days
- Use of vaginal products or lubricant, vaginal intercourse, or douching in the last 24 hour
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Vaginal Infections (BV, VVC, trich)
NAAT testing Amsel criteria Nugent score yeast culture TV culture
|
comparison of NAAT testing for BV, VVC and trich to Amsel criteria, Nugent score, yeast culture and TV culture.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnosis of Vaginal Infections
Time Frame: approximately 7 days
|
Compare the sensitivity and specificity of NAAT tests to Amsel criteria, Nugent score for bacterial vaginosis, yeast culture and TV culture in detecting BV, VVC, and trichomoniasis.
|
approximately 7 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Harold C Wiesenfeld, MD, CM, University of Pittsburgh
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO14010349
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bacterial Vaginosis
-
CDA Research Group, Inc.TerminatedBacterial Vaginosis (BV)United States
-
Zagazig UniversityRecruitingBacterial Vaginosis | Vaginal | MicrobiologyEgypt
-
Starpharma Pty LtdCompletedRecurrent Bacterial Vaginosis (BV)
-
Alfasigma S.p.A.ParexelTerminatedBACTERIAL VAGINOSISUnited States
-
University of Alabama at BirminghamWayne State UniversityCompletedRecurrent Bacterial VaginosisUnited States
-
Zagazig UniversityUnknownBacterial Vaginosis TreatmentEgypt
-
Unity Health TorontoCompleted
-
Mount Sinai Hospital, CanadaUnity Health TorontoCompletedPregnant Women Who Test Positive for Bacterial VaginosisCanada
-
Universiti Kebangsaan Malaysia Medical CentreNot yet recruitingBacterial Vaginoses
-
National Institute of Allergy and Infectious Diseases...Completed
Clinical Trials on NAAT testing
-
University Hospital, Strasbourg, FranceNot yet recruitingChlamydia Trachomatis | Neisseria Gonorrhoeae | Uncomplicated Infections
-
University of PittsburghBecton Dickinson Life SciencesCompleted
-
The Hospital for Sick ChildrenCompleted
-
Democritus University of ThraceUniversity of ThessalyRecruitingRefractive Errors | Vision Disorders | Low VisionGreece
-
Hamilton Health Sciences CorporationRecruiting
-
Democritus University of ThraceUniversity of ThessalyCompletedRefractive Errors | Presbyopia | Low Vision | Near Vision | ReadingGreece
-
Allegheny Singer Research Institute (also known...Active, not recruitingEpithelial Ovarian CancerUnited States
-
Vanderbilt University Medical CenterRecruitingPostural Orthostatic Tachycardia Syndrome | Acute Hepatic PorphyriaUnited States
-
Royal Devon and Exeter NHS Foundation TrustNot yet recruitingHIV Infections | Syphilis Infection | Hepatitis B and Hepatitis CUnited Kingdom
-
University of Alabama at BirminghamRecruitingDepression | Cognitive Impairment | Dementia | ADDUnited States