Vaginosis, Bacterial Clinical Trial
— SAGEOfficial title:
Prospective Multicenter Cross Sectional Study of the American International Biotechnology (AIBiotech) Gynecologene Test for the Evaluation of Bacterial Vaginosis/Vaginitis in Symptomatic Women
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.
Status | Enrolling by invitation |
Enrollment | 300 |
Est. completion date | July 2018 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Unified Clinical Research | Greensboro | North Carolina |
United States | Daniel McDyer OB-GYN | Jacksonville | Florida |
United States | David Greenspan OB-GYN | Phoenix | Arizona |
United States | Desert Jewel Obstetrics and Gynecology | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
American International Biotechnology |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Bacterial Load | identify the prevalence and diagnostic thresholds of bacterial loads found with each specimen using the Gynecologene test. All bacteria will be included and will use the vaginal microbiome to assign specific bacteria. Load will be reported as a percentage of individual bacteria to the total amount found in that sample. Since all samples are unbiquie - identifying every bacteria is not possible. All organisms that have reached the threshold coverage limit within the assay will be reported. Threshold limits are defined within the validation of the Gynecologene assay | 3 months | No |
Primary | 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 | No |
Secondary | Comparison of Sensitivity of Gynecologene to Clinical Diagnosis of BV by Nugent Score (Gold Standard) | calculation of Sensitivity of the condition of BV (true positive rate) using Gynecologene assay as the "test" and Nugent Score as the "gold standard" | 2 weeks after receving sample | No |
Secondary | Comparison of Specificity of Gynecologene to Clinical Diagnosis of BV by Nugent Score (Gold Standard) | calculation of Specificity of the condition of BV (true negative rate) using Gynecologene assay as the "test" and Nugent Score as the "gold standard" | 2 weeks after receving sample | No |
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