Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis

NCT02203942 | Completed

• 1 other identifier: PRO14010349
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Bacterial Vaginosis; Vulvovaginal Candidiasis; Trichomoniasis

Keywords

Bacterial Vaginosis; Vulvovaginal Candidiasis; Trichomoniasis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Vaginal Infections (BV, VVC, trich)

NAAT testing Amsel criteria Nugent score yeast culture TV culture

Other: NAAT testing

Interventions

NAAT testing OTHER

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

Vaginal Infections (BV, VVC, trich)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Enrollments will include patients seeking care at Magee-Womens Hospital.

You may qualify if:

• 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

You may not qualify if:

• Use of oral antibiotics in the past 14 days
• Use of vaginal products or lubricant, vaginal intercourse, or douching in the last 24 hour

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial; Candidiasis, Vulvovaginal; Trichomonas Infections

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Candidiasis; Mycoses; Vulvovaginitis; Vulvitis; Vulvar Diseases; Protozoan Infections; Parasitic Diseases

Study Officials

• Harold C Wiesenfeld, MD, CM

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 25, 2014
• First Posted: July 30, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 27, 2016

Record last verified: 2016-01

Locations

US (1)