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

NCT02558179 | Unknown

• 1 other identifier: SAGE-001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Vaginosis, Bacterial

Outcome Measures

Primary Outcomes (1)

• Evidence of Confirmed BV Through Next Generation Sequencing Gynecologene Assay

  Vaginal swabs meeting inclusion criteria will be assessed for BV using the Gynecologene Assay. Confirmation of BV.

  2 weeks after receiving sample

Secondary Outcomes (2)

• Comparison of Sensitivity of Gynecologene to Clinical Diagnosis of BV by Nugent Score (Gold Standard)

  2 weeks after receving sample

• Comparison of Specificity of Gynecologene to Clinical Diagnosis of BV by Nugent Score (Gold Standard)

  2 weeks after receving sample

Other Outcomes (1)

• Bacterial Load

  3 months

Study Arms (2)

Nugent Score >/= 7

Signs and symptoms of vaginitis/vaginosis, including vaginal discharge, pruritis, irritation, and/or dyspareunia. Diagnosis of bacterial vaginosis (study group) according to Nugent score and/or diagnosis of vulvovaginal candidiasis; and/or diagnosis of Trichomonas vaginalis.

Nugent Score< 7

Signs and symptoms of vaginitis/vaginosis, including vaginal discharge, pruritis, irritation, and/or dyspareunia. Bacterial vaginosis not diagnosed according to Nugent score (\<7).

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women at least 18 years of age will be eligible for this study when diagnosed with bacterial vaginosis or vaginitis confirmed using the CDC (Centers for Disease Control) diagnostic gold standard of Nugent score; Amsel criteria will also be recorded.

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.
• 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.

Sponsors & Collaborators

• American International Biotechnology: lead

Study Sites (4)

David Greenspan OB-GYN

Phoenix, Arizona, 85013, United States

Location

Desert Jewel Obstetrics and Gynecology

Scottsdale, Arizona, 85251, United States

Location

Daniel McDyer OB-GYN

Jacksonville, Florida, 32216, United States

Location

Unified Clinical Research

Greensboro, North Carolina, 27408, United States

Location

Related Publications (12)

• Klebanoff MA, Turner AN. Bacterial vaginosis and season, a proxy for vitamin D status. Sex Transm Dis. 2014 May;41(5):295-9. doi: 10.1097/OLQ.0000000000000124.

  PMID: 24722382 BACKGROUND

• Taylor BD, Darville T, Haggerty CL. Does bacterial vaginosis cause pelvic inflammatory disease? Sex Transm Dis. 2013 Feb;40(2):117-22. doi: 10.1097/OLQ.0b013e31827c5a5b.

  PMID: 23324974 BACKGROUND

• Mitchell C, Manhart LE, Thomas K, Fiedler T, Fredricks DN, Marrazzo J. Behavioral predictors of colonization with Lactobacillus crispatus or Lactobacillus jensenii after treatment for bacterial vaginosis: a cohort study. Infect Dis Obstet Gynecol. 2012;2012:706540. doi: 10.1155/2012/706540. Epub 2012 May 30.

  PMID: 22693410 BACKGROUND

• Swidsinski A, Loening-Baucke V, Swidsinski S, Verstraelen H. Polymicrobial Gardnerella biofilm resists repeated intravaginal antiseptic treatment in a subset of women with bacterial vaginosis: a preliminary report. Arch Gynecol Obstet. 2015 Mar;291(3):605-9. doi: 10.1007/s00404-014-3484-1. Epub 2014 Sep 23.

  PMID: 25245669 BACKGROUND

• Parma M, Stella Vanni V, Bertini M, Candiani M. Probiotics in the prevention of recurrences of bacterial vaginosis. Altern Ther Health Med. 2014 Winter;20 Suppl 1:52-7.

  PMID: 24473986 BACKGROUND

• Marrazzo JM, Thomas KK, Fiedler TL, Ringwood K, Fredricks DN. Relationship of specific vaginal bacteria and bacterial vaginosis treatment failure in women who have sex with women. Ann Intern Med. 2008 Jul 1;149(1):20-8. doi: 10.7326/0003-4819-149-1-200807010-00006.

  PMID: 18591634 BACKGROUND

• Marrazzo JM. Interpreting the epidemiology and natural history of bacterial vaginosis: are we still confused? Anaerobe. 2011 Aug;17(4):186-90. doi: 10.1016/j.anaerobe.2011.03.016. Epub 2011 Apr 16.

  PMID: 21524714 BACKGROUND

• Muzny CA, Sunesara IR, Griswold ME, Kumar R, Lefkowitz EJ, Mena LA, Schwebke JR, Martin DH, Swiatlo E. Association between BVAB1 and high Nugent scores among women with bacterial vaginosis. Diagn Microbiol Infect Dis. 2014 Dec;80(4):321-3. doi: 10.1016/j.diagmicrobio.2014.09.008. Epub 2014 Sep 16.

  PMID: 25262105 BACKGROUND

• Wang B, Xiao BB, Shang CG, Wang K, Na RS, Nu XX, Liao Q. Molecular analysis of the relationship between specific vaginal bacteria and bacterial vaginosis metronidazole therapy failure. Eur J Clin Microbiol Infect Dis. 2014 Oct;33(10):1749-56. doi: 10.1007/s10096-014-2128-5. Epub 2014 May 10.

  PMID: 24816815 BACKGROUND

• Aagaard K, Petrosino J, Keitel W, Watson M, Katancik J, Garcia N, Patel S, Cutting M, Madden T, Hamilton H, Harris E, Gevers D, Simone G, McInnes P, Versalovic J. The Human Microbiome Project strategy for comprehensive sampling of the human microbiome and why it matters. FASEB J. 2013 Mar;27(3):1012-22. doi: 10.1096/fj.12-220806. Epub 2012 Nov 19.

  PMID: 23165986 BACKGROUND

• Srinivasan S, Hoffman NG, Morgan MT, Matsen FA, Fiedler TL, Hall RW, Ross FJ, McCoy CO, Bumgarner R, Marrazzo JM, Fredricks DN. Bacterial communities in women with bacterial vaginosis: high resolution phylogenetic analyses reveal relationships of microbiota to clinical criteria. PLoS One. 2012;7(6):e37818. doi: 10.1371/journal.pone.0037818. Epub 2012 Jun 18.

  PMID: 22719852 BACKGROUND

• van de Wijgert JH, Borgdorff H, Verhelst R, Crucitti T, Francis S, Verstraelen H, Jespers V. The vaginal microbiota: what have we learned after a decade of molecular characterization? PLoS One. 2014 Aug 22;9(8):e105998. doi: 10.1371/journal.pone.0105998. eCollection 2014.

  PMID: 25148517 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Extracted DNA from vaginal swab(s) will be maintained after evaluation for a time period up to 1 year.

MeSH Terms

Conditions

Vaginosis, Bacterial

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

Study Officials

• David G Bostwick, MD

  American International Biotechnology (AI Biotech)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 23, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2018
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (4)