Diagnosing Bacterial Vaginosis/Vaginitis (BV) Using the Gynecologene Test Method

Status unconfirmed

Conditions studied: Vaginosis, Bacterial

In brief

This study is designed as a prospective evaluation of the diagnostic performance of the multiplex nucleic acid-based genetic test (Gynecologene Next-Generation Sequencing test) to identify known significant causative organisms in bacterial vaginosis/vaginitis and other major pathogens and normal commensals in symptomatic women during the reproductive years. Vaginal fluid samples will be split and tested with the comparator methods and Nugent score, with the results evaluated according to sensitivity, specificity, positive predictive value, and negative predictive value. Laboratorians performing each test will be blinded to the clinical history and any prior test results to minimize ascertainment bias. Each subject will be followed routinely for up to 6 weeks after initial visit for vaginosis/vaginitis by telephone or office visit at the discretion of the treating physician.

Key facts

Study ID

NCT02558179

Run by

American International Biotechnology

People needed

300

Starts

2015-09-01

Expected to finish

2018-07-01

Last updated by the study team

2016-07-13

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women ≥ 18 years of age and any race (African-American, Hispanic, Asian/Pacific Islander, native American, white).
• Women during reproductive years prior to menopause and in no case over age 55 years.
• Signed Informed Consent document obtained prior to the initiation of screening procedures.
• Signs and symptoms of vaginitis/vaginosis, including vaginal discharge, pruritis, irritation, and/or dyspareunia.
• Diagnosis of bacterial vaginosis (study group) according to Nugent score (see below); and/or diagnosis of vulvovaginal candidiasis; and/or diagnosis of Trichomonas vaginalis.
• Clinical Diagnosis: Nugent Score: The presence of abnormal vaginal flora at initial diagnosis confirmed by gram stain, with all subjects with BV (bacterial vaginosis or bacterial vaginitis) having Nugent score > 7.
• Inclusion Criteria of Control Group: same as Study Group, but Nugent Score < 7.
• No active major medical or psychological problems that could be complicated by study participation.

You may not qualify if…

• Treatment with any investigational prescription product within 28 days of study screening.
• Post-menopausal or greater than 55 years of age.
• Prior history of hysterectomy or vaginal surgery.
• Prior or currently active autoimmune disease requiring management with systemic immunosuppression for any reason. Such conditions include inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-related thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, sarcoidosis, or other rheumatological disease.
• Any infection requiring parenteral/ enteral antibiotic therapy or causing fever (body temperature > 100.5°F or 38.1°C) within 4 weeks prior to study screening.
• Any medical intervention or other condition which, in the opinion of the Physician-Investigator could compromise adherence with study requirements or otherwise compromise study subject safety and the study's objectives.

Where it is running

• David Greenspan OB-GYN — Phoenix, Arizona, United States
• Desert Jewel Obstetrics and Gynecology — Scottsdale, Arizona, United States
• Daniel McDyer OB-GYN — Jacksonville, Florida, United States
• Unified Clinical Research — Greensboro, North Carolina, United States

Full record on ClinicalTrials.gov

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