Vaginosis, BacterialSAGENCT02558179
Diagnosing Bacterial Vaginosis/Vaginitis (BV) Using the Gynecologene Test Method
An observational study of Vaginosis, Bacterial, run by American International Biotechnology at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginosis, Bacterial
- How many people
- 300 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2015to Jul 2018
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Unified Clinical Research
Greensboro, North Carolina, 27408
Daniel McDyer OB-GYN
Jacksonville, Florida, 32216
David Greenspan OB-GYN
Phoenix, Arizona, 85013
Desert Jewel Obstetrics and Gynecology
Scottsdale, Arizona, 85251
About this study
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.
Read the detailed description
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.
- Conditions
- Vaginosis, Bacterial
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks after receiving sample
Secondary outcomes (2)
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"
Measured: 2 weeks after receving sample
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"
Measured: 2 weeks after receving sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Vaginosis, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- American International Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David G Bostwick, MD, Study director, American International Biotechnology (AI Biotech)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558179
- Sponsor's protocol ID
- SAGE-001
- Acronym
- SAGE
- Status last verified
- Jul 2016
- First submitted
- 22 Sep 2015
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24722382Taylor 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.
PubMed 23324974Mitchell 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.
PubMed 22693410Swidsinski 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.
PubMed 25245669Parma 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.
PubMed 24473986Marrazzo 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.
PubMed 18591634Marrazzo 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.
PubMed 21524714Muzny 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.
PubMed 25262105Wang 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.
PubMed 24816815Aagaard 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.
PubMed 23165986Srinivasan 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.
PubMed 22719852van 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.
PubMed 25148517
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02558179
- Acronym / sponsor ID
- SAGE / SAGE-001
- Conditions
- Vaginosis, Bacterial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- American International BiotechnologyIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evidence of Confirmed BV Through Next Generation Sequencing Gynecologene Assay
Time frame: 2 weeks after receiving sample
Vaginal swabs meeting inclusion criteria will be assessed for BV using the Gynecologene Assay. Confirmation of BV.
2 secondary outcomes
Comparison of Sensitivity of Gynecologene to Clinical Diagnosis of BV by Nugent Score (Gold Standard)
Time frame: 2 weeks after receving sample
Comparison of Specificity of Gynecologene to Clinical Diagnosis of BV by Nugent Score (Gold Standard)
Time frame: 2 weeks after receving sample
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Background: PubMed 24722382Klebanoff 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.
- Background: PubMed 23324974Taylor 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.
- Background: PubMed 22693410Mitchell 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.
- Background: PubMed 25245669Swidsinski 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.
- Background: PubMed 24473986Parma 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.
- Background: PubMed 18591634Marrazzo 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.
- Background: PubMed 21524714Marrazzo 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.
- Background: PubMed 25262105Muzny 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.
- Background: PubMed 24816815Wang 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.
- Background: PubMed 23165986Aagaard 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.
- Background: PubMed 22719852Srinivasan 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.
- Background: PubMed 25148517van 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David G Bostwick, MD study director
American International Biotechnology (AI Biotech)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginosis, Bacterial, run by American International Biotechnology at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of Confirmed BV Through Next Generation Sequencing Gynecologene Assay (time frame: 2 weeks after receiving sample). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02558179, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.