Vaginosis, Bacterial Clinical Trial
Official 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.
Bacterial vaginosis (BV, or vaginal bacteriosis) and vaginitis are the most common vaginal
infections of women during the child-bearing years, with BV alone accounting for 27-41% 1
prevalence in Americans. BV is characterized by replacement of the healthy
lactobacillus-dominant microbiome by a diverse polymicrobial overgrowth of multiple taxa of
commensal facultative anaerobes and other pathogenic bacteria. Molecular-based phylogenetic
analyses, including the newly-completed Human Microbiome Project and other next-generations
sequencing (NGS) studies, revealed the complexity of the vaginal microbiome in health and
disease. BV does not appear to be a single entity, but rather consists of multiple bacterial
community clusters. Clusters are dominated by Lactobacillus iners, Lactobacillus crispatus,
or anaerobic combinations with or without Lactobacillus spp. (species) in varying
proportions. In addition, multiple significant BV-associated pathogens were discovered that
had escaped notice with other detection methods such as cultures; previously overlooked were
Atopobium vaginae, Lactobacillus iners and other Lactobacillus spp., and multiple
Lachnospiraceae spp (Bacterial Vaginosis Associated 1, Bacterial Vaginosis Associated 2, and
Bacterial Vaginosis Associated 3; BVA1, BVA2 and BVA 3 respectively). This multisite study
proposes to evaluate the sensitivity and specificity of the Gynecologene Next-Generation
Sequencing test in women with symptoms of vaginitis/vaginosis. To the investigators'
knowledge, the Gynecologene is the first commercially-available comprehensive NGS-based
laboratory-developed test available to assist with diagnosis and clinical management of BV.
This multisite site study compares the diagnostic performance of the Gynecologene
Next-Generation Sequencing test with the clinical diagnosis of bacterial vaginosis/vaginitis
(Nugent score). The second objective is to compare the sensitivity and specificity of the
Gynecologene Score with the Nugent Score for diagnosis of bacterial vaginosis/vaginitis. The
third objective is to identify the prevalence and diagnostic thresholds of bacterial loads
with the Gynecologene test.
Women between 18-55 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. Other
inclusion as well as exclusion criteria exist. A minimum of 5 geographically different sites
will be enrolled in the study. Co-investigators will follow the protocol to enroll
participants and collect 2 vaginal swabs and 1 slide smear. The patient has no financial
gain nor responsibility within this protocol.
Overall, the study will have 90% power at a significance level of 0.05 to detect ± 5%
positive percent agreement of the study device with the predicate device. To achieve this
level of power, 100 total samples will be assayed per group to account for withdrawals and
treatment failures. Samples that contain more than one targeted organism can be counted
twice as the analyses for each organism are independent of each other. The provision of
treatment, including type, dose, and duration, is solely at the discretion of the clinician
according to his/her current routine procedures to reflect typical contemporary practice.
AIBiotech will serve as a central medical diagnostic laboratory for this trial. Results of
all analytical tests will be provided to the Principal Investigator.
Data for analysis will be blinded for patient identification and other PHI (protected health
information) by the study administrator. Data will be analyzed and reported.
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Observational Model: Cohort, Time Perspective: Prospective
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