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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02203942
Other study ID # PRO14010349
Secondary ID
Status Completed
Phase N/A
First received July 25, 2014
Last updated January 26, 2016
Start date July 2014
Est. completion date June 2015

Study information

Verified date January 2016
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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).


Description:

Several commercial nucleic acid amplification tests (NAAT) are available to identify causative organisms. One of these commercial tests has undergone validation published in a scientific journal, only in an STD clinic population. The primary outcome of this study is to compare NAAT diagnostic methods to traditional gold-standard tests for BV, VVC and TV in symptomatic and asymptomatic women in the general gynecology office as well as in a vulvovaginitis referral office. Addressing incorrect evaluation and diagnosis will lead to correct treatment for women suffering from vaginitis.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Female participants aged 18 and older

2. Based on symptoms:

- Symptomatic patients: with symptoms of vaginitis that include abnormal discharge, malodor, itching, irritation and / or discomfort

- Asymptomatic controls: no vulvovaginal symptoms

3. Willing to provide written informed consent for participation in this study

Exclusion Criteria:

1. Use of oral antibiotics in the past 14 days

2. Use of vaginal products or lubricant, vaginal intercourse, or douching in the last 24 hour

Study Design

Observational Model: Case-Only


Intervention

Other:
NAAT testing
comparison of NAAT testing for BV, VVC and trich to Amsel criteria, Nugent score, yeast culture and TV culture.

Locations

Country Name City State
United States Magee-Womens Hospital of UPMC Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnosis of Vaginal Infections 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 No
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