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Oral Session #5 (Sat am, 10:45-11:45)
Scientific Oral Presentation Session 5 
Moderator: Dr. Brenna Anderson  High Resolution Profiling of the Vaginal Microbiome of  Healthy, Reproductive Aged Canadian Women  A Multicenter, Randomized, Placebo controlled, Parallel‐ Group, Double Blinded Study to Compare the Therapeutic  of 3 Single Vaginal Doses of Arasertaconazole Nitrate Pessaries in the Treatment of the Vulvovaginal Candidiasis   Fluconazole Resistant Candida Albicans Vulvovaginitis (VVC)?  Wayne State University School of  Antifungal Susceptibility and Therapy Outcome in  Vulvovaginal Candidiasis Caused by Candida Glabrata  Peking University Shenzhen Hospital  Shenzhen,Guangdong, PR China   HIGH RESOLUTION PROFILING OF THE VAGINAL MICROBIOME OF
HEALTHY, REPRODUCTIVE AGED CANADIAN WOMEN
J.E. Hill1,*; M.G. Links1,2; B. Chaban1; T. Paramel Jayaprakash1; C. Fernando1; S.M. Hemmingsen3; G. Reid4; J. van Schalkwyk5; D.M. Money5 1Department of Veterinary Microbiology, University of Saskatchewan, Saskatoon, SK, Canada; 2Saskatoon Research Centre, Agriculture and AgriFood Canada, Saskatoon, SK, Canada; 3NRC Plant Biotechnology Institute, Saskatoon, SK, Canada; 4Lawson Health Research Institute and University of Western Ontario, London, ON, Canada; 5Women's Health Research Institute and University of British BACKGROUND:
Next-generation sequencing studies of the vaginal microbiome to date are almost
exclusively based on the 16S rRNA gene. The cpn60 gene has been established as an
alternative metagenomic target that offers advantages including superior species
resolution and improved representation of some bacterial taxa in complex communities.
METHODS:
32 reproductive-aged women who were asymptomatic for BV, reported regular
menstrual cycles, no use of hormonal birth control or IUD, and no recent use of
antimicrobial medication were recruited. Vaginal swabs were self-collected weekly for 1
month. Universal cpn60 PCR product libraries and a mollicutes-specific library
containing pooled PCR products from 12 samples (12 women) were subjected to
pyrosequencing on the 454 platform using Titanium chemistry. A subset of samples
was also examined by species-specific qPCR for Gardnerella vaginalis.
RESULTS:
Nugent scores for all samples ranged from 1 to 8 (mean 3.6, median 3). cpn60 profiles
of 78 samples from 28 women were generated. Species prevalent in >50% of samples
and >90% of women included Lactobacillus crispatus, iners and jensenii, G. vaginalis
and Bifidobacterium breve. G. vaginalis observations were supported by qPCR results.
Nine distinct species of Bacteroides and Prevotella were also identified.
CONCLUSIONS:
Our data suggest that G. vaginalis and Bifidobacteirum breve are more prevalent in
women without BV than previously reported. The cpn60 universal target simplifies
species-level resolution of the vaginal microbiome.
A MULTICENTER, RANDOMIZED, PLACEBO CONTROLLED,
PARALLEL-GROUP, DOUBLE BLINDED STUDY TO COMPARE THE
THERAPEUTIC EFFICACY, SAFETY, AND TOLERABILITY OF 3
SINGLE VAGINAL DOSES OF ARASERTACONAZOLE NITRATE
PESSARIES IN THE TREATMENT OF VULVOVAGINAL CANDIDIASIS
T. Baleeiro1; S. Gropper1; N. Marti1; A. Guglietta1 and the Arasertaconazole Phase II 1 R&D Center, Ferrer Internacional , Barcelona, Spain BACKGROUND:
Arasertaconazole nitrate is a new topical antimycotic which has shown a wide spectrum
of activity against yeasts, dermatophytes and molds. It has shown to have in vitro
activity against C.albicans and all organisms involved in VVC, as C.glabrata, C.krusei,
described as resistant to other treatments.
METHODS:
A multicenter, randomized, placebo controlled, parallel-group,double blinded study to
compare the therapeutic efficacy, safety, and tolerability of 3 single vaginal doses of
arasertaconazole nitrate pessaries (150, 300 and 600 mg).
RESULTS:
Multicenter study, including 24 sites from France, CZRepublic, Ukraine, Hungary,
Russia, Lithuania, where 229 patients, mean age 31±8 years were randomized. Clinical,
mycological and global cure were assessed at Day 8±2 (visit 2) and Day 26±4 (visit 3).
Preliminar analysis FAS show global therapeutic cure at visit 2: 17.5% for placebo,
36.1% Arasertaconazole 150 mg, 46.3% Arasertaconazole 300 mg, 61%
Arasertaconazole 600 mg, p < 0.0001(CI 95%). Preliminar analysis PPS show global
therapeutic cure at visit 2: 17.6% for placebo, 31% Arasertaconazole 150 mg, 48.3%
Arasertaconazole 300 mg, 58.8% Arasertaconazole 600 mg, p=0.0003(CI 95%).
Mycological response at visit 2: 30.6% for placebo, 77.4 % Arasertaconazole 150 mg,
71.8 % arasertaconazole 300 mg, 78% Arasertaconazole 600 mg, p< 0.05(CI 95%). No
SAE was notified.
CONCLUSION:
A single administration of Arasertaconazole nitrate pessary shows a clear dose-
response. All doses were found safe and well tolerated. Further analysis are being
provided.
FLUCONAZOLE RESISTANT CANDIDA ALBICANS VULVOVAGINITIS
(VVC) – AN EMERGING PROBLEM
Division of Infectious Diseases, Wayne State University School of Medicine, Detroit, MI BACKGROUND:
Fluconazole oral therapy has become established as the dominant therapy for VVC
worldwide. Regimens include single and multiple dose regimens for acute VVC and low
dose long term weekly maintenance regimens for recurrent VVC. Previously short term
(1 year) follow up, failed to reveal emergence of fluconazole resistance.
METHODS:
Retrospective review of charts of patients referred to Vaginitis Clinic at WSU between
2000 and 2010 revealed 25 patients with clinically refractory fluconazole-resistant VVC
with confirmed in vitro resistance, MIC > 2 µg/mL. After chart review, patients
completed a questionnaire pertaining to demographic, co-morbidities, behavioral
characteristics and antimicrobial/antifungal exposure and finally therapeutic intervention
of refractory VVC.
RESULTS:
Study cohort (n=25) consists of married, insured, Caucasian women, with > 12 years of
formal education, above average socioeconomic status. Risk factors for refractory VVC
included multiple (>10) lifetime sexual partners (p = 0.03), recent use of antibiotics
(p=0.04) and for mycological failure included increased fluconazole exposure (p=0.03)
and older age of VVC onset (p=0.04). Strain typing using Rep PCR revealed
polyclonality.
CONCLUSION:
Refractory fluconazole-resistant C. albicans VVC was previously considered rare. We
report 25 cases over a 10 year period indicating an emerging problem. All patients had
significant fluconazole consumption in previous six months. Management options of
fluconazole refractory disease are extremely limited and new therapeutic modalities are
needed.
Sobel JD, Wiesenfeld HC, Martens M, Danna P, Hooton TM, Rompalo A, Sperling M, Livengood C 3rd, Horowitz B, Von Thron J, Edwards L, Panzer H, Chu TC. Maintenance fluconazole therapy for recurrent vulvovaginal candidiasis. N Engl J Med. 2004 351:876-83. Richter SS, Galask RP, Messer SA, Hollis RJ, Diekema DJ, Pfaller MA. Antifungal susceptibilities of Candida species causing vulvovaginitis and epidemiology of recurrent cases. J Clin Microbiol. 2005 43:2155-62. Sobel JD, Zervos M, Reed BD, Hooton T, Soper D, Nyirjesy P, Heine MW, Willems J, Panzer H. Fluconazole susceptibility of vaginal isolates obtained from women with complicated Candida vaginitis: clinical implications. Antimicrob Agents Chemother. 2003 47:34-8. ANTIFUNGAL SUSCEPTIBILITY AND THERAPY OF VULVOVAGINAL
CANDIDIASIS CAUSED BY CANDIDA GLABRATA
1 Department of Obstetrics and Gynecology and 2 Department of Laboratory Science, Peking University Shenzhen Hospital, Shenzhen, 518036 China BACKGROUND:
To study antifungal susceptibility and therapy outcome for vulvovaginal candidiasis
(VVC) caused by Candida glabrata.
METHODS:
The study involved a prospective, sequential, non-randomized clinical trial of antifungal
therapies and in vitro susceptibility study. All strains were identified using the API
Candida. In vitro susceptibility was tested using a Rosco agar diffusion method. The
patients were treated with Nystatin vaginal tablets (20 MU/day for 7 days), Miconazole
Nitrate vaginal suppository(two 1200mg doses 72 hours apart), oral Fluconazole (two
150 mg doses 72 hours apart) or oral Itraconazole（200mg ,b.i.d, for one day）from
separate clinical trials. Mycological cure or failure was defined according to a positive or
negative Candida culture at follow-up.
RESULTS:
In vitro susceptible rate of Candida glabrata on Miconazole, Nystatin, Fluconazole, and
Itraconazole were 89.5% (51/57), 100% (57/57), 58.0% (40/69), and 86.6% (58/67);
Susceptible-dose-dependent rate were 10.5% (6/57) , 0(0/57) , 39.1% ( 27/69), and
11.9% (8/67). Mycological cure rate of therapy with Miconazole, Nystatin, Fluconazole,
and Itraconazole were 42.1% (8/19), 93.7% (15/16), 55.6% (5/9) and 46.7% (7/15) at
day 7-14 fowllw up. Mycological cure rate of therapy with above antifungal agents were
31.6% (6/19), 93.7% (15/16), 55.6% (5/9) and 40.0% (6/15) at day 30-35 follow up.
CONCLUSIONS:
Nystatin vaginal suppository should be a therapy choice for VVC caused by Candida
glabrata

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